Indications united states food and drug administration. Medical search. Frequent questions

These recommendations apply to all licensed influenza vaccines used within Food and Drug Administration (FDA)-licensed indications. (cdc.gov)

BOSTON, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases, today announced that the European Medicines Agency (EMA) has issued a positive opinion on the Company's orphan drug designation request for setmelanotide as a treatment for acquired hypothalamic obesity. (fox2now.com)
The letter generally confirmed the Company's previously-announced indications from the FDA based on telephone discussions. (salesandmarketingnetwork.com)
State Street Corp now owns 72,594 shares of the company's stock worth $256,000 after purchasing an additional 5,471 shares during the period. (defenseworld.net)

5, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration ( FDA ) for Descovy ® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV. (gilead.com)
In May 2022, the supplemental new drug application ("sNDA") for toripalimab in combination with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic ESCC was approved by the NMPA in China. (itbusinessnet.com)

1 Similarly, in 2019, Dysport received FDA approval for the treatment of upper limb spasticity in children two years of age and older, excluding upper limb spasticity caused by CP, due to Orphan Drug exclusivity granted to another manufacturer. (biospace.com)

NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma. (wkrn.com)
In the United States, it has received Breakthrough Therapy designation [from] the U.S. Food and Drug Administration (FDA) for recurrent, metastatic nasopharyngeal carcinoma, as well as Fast Track and Orphan Drug status for other cancer types. (ascopost.com)
Lonafarnib has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and Fast Track and now Breakthrough designation by U.S. FDA. (researchandmarkets.com)
In the the United States, the NPC indications of toripalimab have been granted 2 Breathrough Therapy Designations and 1 Orphan Drug Designation by the Food and Drug Administration ("FDA"), while the Biologics License Application ("BLA") for toripalimab for the treatment of NPC is under review. (itbusinessnet.com)
Additionally, US FDA has also granted an orphan drug designation to toripalimab for the treatment of patients with ESCC. (itbusinessnet.com)
EMA orphan drug designation is granted to drugs intended for the treatment, diagnosis, or prevention of life-threatening or chronically debilitating conditions affecting no more than five in 10,000 individuals in the European Union. (fox2now.com)

Therefore, the use of medications for indications beyond those formally evaluated is allowable in medical clinical practice. (elsevier.com)
At this time, most of the drugs selected are neither specialty medications (which are used to treat rare, complex, and chronic health conditions), nor do they have high out-of-pocket costs for Part D beneficiaries. (americanactionforum.org)
ASHP is also the publisher of the American Hospital Formulary Service Drug Information (AHFS DI), a comprehensive, independent reference on the clinical use of medications marketed in the United States. (cms.gov)
It is deeply disturbing to hear parents declare that they have become convinced that their child needs to be constantly drugged and will probably continue to need these medications for life. (davidhealy.org)

Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab)* for all eligible indications of the reference product. (pfizer.com)
KENILWORTH, N.J. - Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade. (merck.com)
The application seeks approval for use in all therapeutic indications currently approved for Remicade for which marketing exclusivity has expired. (merck.com)

[i] A University of Chicago study found that the IRA provisions will likely reduce manufacturer investment by 29 to 60 percent in R&D from 2021 to 2039, which translates into 167 to 342 fewer new drug approvals during that period. (americanactionforum.org)
On July 23, 2021, the Food and Drug Administration expanded the indication for use of recombinant zoster vaccine (RZV) to include immunodeficient or immunosuppressed adults. (cdc.gov)
On July 23, 2021, the FDA expanded the indication for recombinant zoster vaccine (RZV) to include adults aged ≥18 years who are or will be at increased risk for herpes zoster because of immunodeficiency or immunosuppression caused by known disease or therapy ( 2 ). (cdc.gov)
In 2021, two indications for the treatment of NPC were approved by the China National Medical Products Administration ("NMPA"), thereby making toripalimab the world's first immune checkpoint inhibitor approved for the treatment of NPC. (itbusinessnet.com)

In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Hepatitis D collaborations, licensing, mergers and acquisition, funding, designations and other product related details. (researchandmarkets.com)

LOS ANGELES, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. ("Nexcella", "Company", "We" or "Us"), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for BCMA CAR-T NXC-201 (formerly HBI0101). (wkrn.com)
therefore, CDC received Investigational New Drug (IND) approval (BB-IND-7596) from the Food and Drug Administration. (cdc.gov)

The Food and Drug Administration's approval came with a Risk Evaluation and Mitigation Strategy (REMS) because of the risk for serious adverse events, including cytokine release syndrome. (medscape.com)
The United States Food and Drug Administration (FDA) focuses on regulating the approval of prescription drugs rather than regulating the prescribing practices of physicians. (elsevier.com)
The full and ultimate use of a drug is rarely evident at the time of initial FDA-approval or marketing. (elsevier.com)
The discovery and clinical adoption of new uses for marketed drugs or for investigational drugs often precedes FDA approval of such uses. (elsevier.com)
continued approval for these indications may be contingent upon verification and description of clinical benefit in the confirmatory trials. (merck.com)
Being the first FDA approved drug against the severe disease hATTR amyloidosis Alnylam´s new product ONPATTRO has the potential to bring relief to many patients in the US and, as the company files for approval of patisiran by other Regulatory agencies, hopefully across the world. (mpg.de)
Drug information typically includes the drug name, approval status, indication of use, and clinical trial results. (centerwatch.com)
These recommendations do not represent approval by the Food and Drug Administration (FDA) or approved labeling for the particular products or indications in question. (cdc.gov)
Specifically, the terms ``safe'' and ``effective'' are not synonymous with the FDA-defined legal standards for drug approval. (cdc.gov)
On 17th November, Janssen Biotech, Inc. announced the submission of a Biologics License Application to the United States Food and Drug Administration seeking approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis. (prnewswire.co.uk)

In October 2015, the Food and Drug Administration (FDA) instituted an update to the mandatory Risk Evaluation and Mitigation Strategy (REMS) program for clozapine to improve safety monitoring of hematologic events. (allenpress.com)

On August 29, 2023, the Department of Health and Human Services announced the first 10 drugs selected for negotiation with the negotiations expected to occur in late 2023 and early 2024. (americanactionforum.org)

1 Dysport has approved indications in the United States for the treatment of adults with cervical dystonia (CD) and for the treatment of spasticity in adult patients. (biospace.com)
The United States Food and Drug Administration (FDA) approved the first-of-its-kind RNA interference (RNAi) therapeutic patisiran (Onpattro) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. (mpg.de)
The US Food and Drug Administration (FDA) has expanded the indication for belimumab (Benlysta) to adults with active lupus nephritis who are receiving standard therapy. (medscape.com)
Belimumab IV infusion was first approved in the United States in March 2011 for adults with SLE. (medscape.com)
Both the IV and subcutaneous formulations are now indicated in the United States for adults with SLE and LN. (medscape.com)
Cite this: FDA Expands Belimumab Indication to Adults With Lupus Nephritis - Medscape - Dec 18, 2020. (medscape.com)
Zoster Vaccine Recombinant, Adjuvanted (Shingrix, GlaxoSmithKline [GSK]) is a 2-dose (0.5 mL each) subunit vaccine containing recombinant glycoprotein E in combination with adjuvant (AS01 B ) that was licensed in the United States for prevention of herpes zoster for adults aged ≥50 years by the Food and Drug Administration (FDA) and recommended for immunocompetent adults aged ≥50 years by the Advisory Committee on Immunization Practices (ACIP) in 2017* ( 1 ). (cdc.gov)
This preparation of sodium deoxycholate 10mg/mL was approved for the aesthetic improvement of "moderate-to-severe convexity or fullness associated with submental fat in adults," and is the first FDA-approved drug for injection adipolysis. (jcadonline.com)

The United States Food and Drug Administration (FDA) recently approved a formulation of sodium deoxycholate 10mg/mL for subcutaneous injection with the indication of aesthetic improvement of excess submental fat. (jcadonline.com)
However, previous research leading to the development of this drug proposed that including phosphatidylcholine to a more appealing cosmetic result, with decreased severity of injection-site reactions. (jcadonline.com)
Future drugs in the field of injection adipolysis may attempt to combine these ingredients for improved cosmesis and tolerability. (jcadonline.com)
The FDA has expressed a concern about a relatively small number of patients in European post-marketing use who have experienced respiratory symptoms immediately following the intramuscular injection of NEBIDO 1000 mg, 4 cc injection volume, (versus the 750 mg, 3 cc injection volume used in the United States). (salesandmarketingnetwork.com)
FDA has also requested the Company provide a plan to minimize the risks associated with the clinical use of testosterone undecanoate intramuscular injection, namely, to reduce the incidence and/or severity of the serious oil-based reactions and has requested certain in vitro and skin-testing data to exclude an allergic component to the drug or some of its excipients. (salesandmarketingnetwork.com)
Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus stated, "We believe that NEBIDO is a safe and effective drug for its intended use and continue to be disappointed that the FDA was not willing to approve the drug at this time with adequate labeling of the oil-based reactions and how to minimize them with proper injection technique. (salesandmarketingnetwork.com)
PrEP is indicated for men and women with sexual or injection drug use behaviors that increase their risk for acquiring HIV ( 5 ). (cdc.gov)

There is evidence that probiotics should potentially be avoided in patients at higher risk for infection , such as those with indwelling lines, in the intensive care unit, or in immunocompromised states. (medscape.com)
In the United States , Descovy is approved in combination with other antiretroviral agents for the treatment of HIV infection in patients weighing ≥25 kg and is not indicated for PrEP. (gilead.com)
the Truvada label also carries a Boxed Warning for the risk of drug resistance with PrEP in undiagnosed early HIV infection. (gilead.com)
Preexposure prophylaxis (PrEP) with a daily, oral pill containing antiretroviral drugs is highly effective in preventing acquisition of human immunodeficiency virus (HIV) infection ( 1 - 4 ). (cdc.gov)
TB skin testing was added to the NHANES 1999-2000 examination to provide comprehensive data about the extent of tuberculosis infection in the United States. (cdc.gov)

When Dysport was first FDA-approved in 2016 for pediatric lower limb spasticity, Ipsen was granted Orphan Drug exclusivity for pediatric patients whose lower limb spasticity was caused by cerebral palsy (CP). (biospace.com)
Sanvar(R) has been granted orphan drug status in the US and received an approvable letter from the FDA in 2004. (salesandmarketingnetwork.com)
If approved, toripalimab will be the first and only drug approved for the treatment of NPC in the U.S. In Europe, toripalimab was designated as an orphan medicinal product by the European Commission ("EC") for the treatment of NPC. (itbusinessnet.com)

[ 8 , 5 ] Because of the risk of migration, polytetrafluoroethylene is not approved by the United States Food and Drug Administration (FDA) for treatment of female stress urinary incontinence. (medscape.com)
The indication is for use in patients who have received at least two lines of treatment. (medscape.com)
A 1996 GAO report (Prescription Drugs, Implications of Drug Labeling and Off-Label Use) has shown that "off-label" drug use (e.g., the use of a drug for an indication not approved by the FDA) is substantial in situations where satisfactory treatment is not available and that there are lower rates of off-label use when there is an effective therapy. (elsevier.com)
Off-label drug indication data are included in our drug information database when identified as a clinically relevant or emerging treatment by the drug information editorial team. (elsevier.com)
The U.S. Food and Drug Administration (FDA) issued a complete response letter for ruxolitinib extended-release (XR) tablets for once-daily (QD) use in the treatment of certain types of MF, PV and GVHD. (businesswire.com)
Onpattro is the first and only FDA-approved treatment for this indication. (mpg.de)
NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, relapsed/refractory multiple myeloma, and potentially expanding into autoimmune indications: systemic lupus erythematosus (SLE), myasthenia gravis (MG), and multiple sclerosis (MS). (wkrn.com)
LAUSANNE, Switzerland, June 1 (Healthcare Sales & Marketing Network) - The Debiopharm Group, a global independent biopharmaceutical development company specialising in oncology and serious medical conditions, announced today its initiation of a confirmatory Phase III study for Sanvar(R) in the United States (US), for the treatment of acute esophageal variceal bleeding (EVB) secondary to portal hypertension. (salesandmarketingnetwork.com)
US Food and Drug Administration (FDA) approved indications include treatment-resistant schizophrenia as well as suicidal behavior in schizophrenia or schizoaffective disorder. (allenpress.com)
1 Clozapine has been shown to be 1 of the most effective treatment options available for these 2 indications and is recommended as a potential first-line treatment option. (allenpress.com)
Medtronic is currently involved in a pivotal SLATE (Stereotactic Laser Ablation for Temporal Lobe Epilepsy) study in the United States to support an expanded FDA indication for the treatment of epilepsy in patients with drug-resistant mesial temporal lobe epilepsy (MTLE), the most common form of partial or localization related epilepsy. (medgadget.com)
Additionally, findings from a Phase 2 study evaluating guselkumab in the treatment of patients with active psoriatic arthritis were recently presented at the American College of Rheumatology meeting and a Phase 3 program for this indication is planned. (prnewswire.co.uk)
ASHP recommends that CMS not include the DrugDex database in its list of compendia used to determine medically accepted indications for drugs and biologicals used in anti-cancer treatment, unless CMS determines that DrugDex meets the MedCAC criteria. (cms.gov)
Aranesp was approved by the U.S. Food and Drug Administration in 2001 for the treatment of anemia associated with CRF for patients on dialysis and patients not on dialysis. (worldpharmanews.com)
Initial attempts in the field utilized intravenous preparations of sodium deoxycholate and soy-derived phosphatidylcholine, approved for the intravenous treatment of fat emboli and dyslipidemias in countries outside the United States. (jcadonline.com)

For example, in the United States, the Food and Drug Administration approved a prevention indication for TDF/FTC and the Centers for Disease Control and Prevention has recommended it, but availability is via private insurance, Medicaid and demonstration projects. (avac.org)

In APOLLO, the safety and efficacy of the drug were evaluated in a diverse, global population of hATTR amyloidosis patients in 19 countries, with a total of 39 TTR mutations. (mpg.de)
Despite rampant use in Brazil, with thousands of patients seeking injections for cellulite, back rolls, and lower eyelid fat pad herniation, Lipostabil was banned in December 2002 for cosmetic use by ANVISA, the Brazilian equivalent of the FDA, as there were no clinical trials supporting efficacy or safety of the drug. (jcadonline.com)

ADR: IPSEY), announced today that the United States Food and Drug Administration (FDA) has approved the expanded use of Dysport ® (abobotulinumtoxinA) in pediatric patients. (biospace.com)
Its full indication is to reduce the duration of neutropenia and incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancies, with the exception of chronic myeloid leukemia (CML) and myelodysplastic syndromes. (medscape.com)
[ 10 ] In 2001, VCE was approved by the US Food and Drug Administration (FDA) for use in patients in the United States, and by 2003, capsule endoscopy had already been used in more than 4000 patients. (medscape.com)
The expanded indication for belimumab for patients with LN is based on findings from the BLISS-LN phase 3 trial, published in The New England Journal of Medicine in September. (medscape.com)
At this point, we really follow the FDA [United States Food and Drug Administration] indication for these patients. (urologytimes.com)
This is emblematic of our determination and corporate efficiency in bringing innovative drugs to patients worldwide. (itbusinessnet.com)
In the United States, setmelanotide is indicated for chronic weight management in adult and i pediatric patients 6 years of age and older with monogenic or syndromic obesity due to POMC, PCSK1 or LEPR deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1 or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) and BBS. (fox2now.com)
The Food and Drug Administration (FDA)-approved prescribing information for eculizumab includes a black box warning for increased risk of meningococcal disease, and the Advisory Committee on Immunization Practices (ACIP) recommends meningococcal vaccination for all patients receiving eculizumab. (cdc.gov)
AVAREF Chair Dr Beno Yakubu said, "Under the platform of AVAREF, this meeting is an indication of the due diligence taken by the pharmaceutical companies and partners to jointly ensure that the clinical trial process is of the highest ethical and scientific standards to ensure the safety of the volunteers and patients who will ultimately receive the vaccine. (who.int)

CDC analyzed 2014-2016 data from the IQVIA Real World Data - Longitudinal Prescriptions (IQVIA database) to estimate the number of persons prescribed PrEP (users) in the United States and to describe their demographic characteristics, including sex and race/ethnicity. (cdc.gov)
Approximately 7% of the estimated 1.1 million persons who had indications for PrEP were prescribed PrEP in 2016, including 2.1% of women with PrEP indications ( 6 ). (cdc.gov)
Data on antiretroviral drug prescriptions dispensed during 2014-2016 were extracted from the IQVIA database,* which captured prescriptions from all payers and represented approximately 92% of all prescriptions dispensed from retail pharmacies and 60%-86% dispensed from mail order outlets in the United States. (cdc.gov)

Toripalimab is currently approved in China for several indications, including in the third-line setting for metastatic nasopharyngeal carcinoma. (ascopost.com)
SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the company has submitted a marketing authorization application ("MAA") to the United Kingdom's Medicines and Healthcare products Regulatory Agency ("MHRA") for toripalimab. (itbusinessnet.com)
Junshi Biosciences also submitted a MAA to the European Medicines Agency ("EMA") for toripalimab for the same indications in mid-November. (itbusinessnet.com)

Yet if a drug manufacturer can launch a new product across all 27 EU member states within two years, it will receive back two years of patent exclusivity - a goal that would be extraordinarily difficult to meet and would likely reduce launches of new medicines. (americanactionforum.org)

The database included antiretroviral drugs dispensed, demographic variables of persons to whom the drugs were dispensed, and medical claims for these persons. (cdc.gov)

Rhythm's lead asset, IMCIVREE (setmelanotide) is approved by the U.S. Food and Drug Administration (FDA) and authorized by the European Commission (EC) and the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) for use in accordance with product labeling. (fox2now.com)
12],[13] The Medicines and Healthcare Products Regulatory Agency in the United Kingdom and the FDA subsequently issued strong warnings against their use. (jcadonline.com)
LifeMD, Inc operates as a direct-to-patient telehealth company that connects consumers to healthcare professionals for care across various indications, including urgent and primary care, men's and women's health, and dermatology, chronic care management, and others in the United States. (defenseworld.net)
The meeting facilitated by WHO under the platform of the African Vaccine Regulatory Forum (AVAREF) was attended by 60 expert representatives of the Ethics Committee and the Pharmacy Board of Sierra Leone with support from Ghana's Food and Drug Authority (GFDA), Health Canada, the European Medicines Agency, the Medicines and Healthcare Products Regulatory Agency (MHRA) United Kingdom, and the United States Food and Drug Administration (US FDA). (who.int)
Their use in healthcare settings dates to the 1990s in response to concerns about employee exposures to drug-resistant tuberculosis. (cdc.gov)

As a result, the various admixtures, indications, and different strains of probiotics in the products being advertised are largely unregulated. (medscape.com)
The Debiopharm Group independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs. (salesandmarketingnetwork.com)
It covers the pipeline drug profiles, including clinical and nonclinical stage products. (researchandmarkets.com)

In addition to the EU, the combination has been approved in six countries, including the United States, and additional regulatory applications are under review by global health authorities. (pharmiweb.com)
This document provides information to WHO Member States, manufacturers submitting to the WHO Prequalification of Diagnostics Programme, regulators and other stakeholders on an internationally recognized risk-based approach to the regulatory assessment of IVDs to determine the level of scrutiny of the assessment of an IVD and to assure there quality, safety and performance in clinical use. (who.int)

Nasopharyngeal carcinoma, a rare tumor of the head and neck, accounts for less than one case for every 100,000 people each year in most parts of the world, including the United States. (ascopost.com)

Evaluation of the vaccine regimen commenced with Phase I clinical trial at the Oxford Vaccine Group in December 2014 and this has been followed by Phase 1 studies in the United States (US) and Africa (Kenya, Uganda, Tanzania). (who.int)
Only the 9-valent vaccine is now available in the United States. (msdmanuals.com)

Elsevier will rate all off-label indications using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system.1-6 Each off-label use will be assigned a quality of evidence rating and a strength of recommendation by the Elsevier drug information editorial team. (elsevier.com)
The decision was made in consultation with the FDA following the April 29 Oncologic Drugs Advisory Committee evaluation of this third-line gastric cancer indication for KEYTRUDA as a monotherapy because it failed to meet its post-marketing requirement of demonstrating an overall survival benefit in a Phase 3 study. (merck.com)

The policy implications on coverage decisions were substantial, costing state Medicaid programs considerable resources. (cms.gov)

The gap between numbers of persons with PrEP indications and those prescribed PrEP was substantial, especially among persons in female, black, and Hispanic populations. (cdc.gov)

Our first quarter results demonstrate continued year-over-year double-digit revenue growth driven by Jakafi, which grew across all indications, and Opzelura, which is on track to become one of the most successful dermatology launches in recent years. (businesswire.com)

Injured by a prescription drug or defective medical device? (drugwatch.com)
We've also connected thousands of people injured by drugs and medical devices with top-ranked national law firms to take action against negligent corporations. (drugwatch.com)

There is even some cause to believe that Europe could overtake the United States in PrEP implementation. (avac.org)
One of the key challenges of PrEP uptake in the United States is developing systems and educating providers to deliver PrEP. (avac.org)
Focused efforts are needed to increase the impact of PrEP in the United States. (cdc.gov)
The combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) is the only medication approved by the Food and Drug Administration (FDA) for PrEP. (cdc.gov)
Although black men and women accounted for approximately 40% of persons with PrEP indications ( 6 ), this study found that nearly six times as many white men and women were prescribed PrEP as were black men and women. (cdc.gov)
The findings of this study highlight gaps in effective PrEP implementation efforts in the United States. (cdc.gov)
Because racial and ethnic disparities in HIV diagnoses exist in the United States ( 9 ), it is also important to better understand PrEP use by race/ethnicity. (cdc.gov)

The Debiopharm Group is a global biopharmaceutical development company that in-licenses promising biologics and small molecule drug candidates. (salesandmarketingnetwork.com)

The United States Food and Drug Administration (FDA) has currently approved it as a Schedule IV prescription drug. (healthmatter.co)

The product is already approved in the United States for the same indication. (medscape.com)
The exclusive inclusion of only "labeled" information (e.g., uses for or information about a drug approved by the FDA and included within the FDA-approved product labeling) within our database would limit the utility and scope of our information to clinicians. (elsevier.com)
Elsevier drug information includes off-label indications and other clinical data for drug therapy that may be outside the scope of the FDA-approved drug product labeling. (elsevier.com)
It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. (researchandmarkets.com)

Previous Phase III trials for Sanvar(R) in this indication were conducted in Europe. (salesandmarketingnetwork.com)
6+ key companies which are developing the therapies for Hepatitis D. The companies which have their Hepatitis D drug candidates in the most advanced stage, i.e. phase III include, Eiger Biopharmaceuticals. (researchandmarkets.com)

The United Kingdom and European Union member states are pursuing similar strategies to reduce spending in their procurement and reimbursement of medicines - potentially with similar problematic outcomes. (americanactionforum.org)
This BLA is the first application filed in the United States by Samsung Bioepis as part of its partnership with Merck to offer biosimilar alternatives to existing biologic medicines. (merck.com)

The FDA stated that depending on the findings, the number of subjects and the number of injections of testosterone undecanoate from the studies listed above, the safety database may need to include data from additional clinical studies. (salesandmarketingnetwork.com)

Early advocacy is already happening in France, Germany and the United Kingdom. (avac.org)

The ECDC comment in contrast vacillated, articulating questions about cost and concerns about side effects, potential for drug resistance and condom migration that experience and research have shown so far to be of manageable or minimal impact. (avac.org)

Having a strong therapeutic pipeline with several RNAi candidates in advanced stages we are looking forward to see Alnylam bring more RNAi-based drugs on the market soon," says Jörn Erselius, CEO of Max Planck Innovation, the technology transfer organization of the Max Planck Society. (mpg.de)

5 Clozapine has several black box warnings regarding potential severe adverse drug reactions (ADRs), including hematologic abnormalities. (allenpress.com)

With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States. (wkrn.com)
NXC-201's favorable tolerability profile, including overcoming neurotoxicity, potentially enables expansion beyond AL Amyloidosis into autoimmune indications. (wkrn.com)

The highest disease incidence in recent years has been reported from the Baltic states (Estonia, Latvia, Lithuania), Czech Republic, and Slovenia. (cdc.gov)

As surgeons continue to gain experience with VCE technology, the list of indications for capsule endoscopy continues to grow. (medscape.com)

In order to represent such best practices in drug therapy, the Elsevier drug information editorial team follows a policy for content style and production, which includes a specific policy regarding off-label drug indication data. (elsevier.com)

The US Food and Drug Administration (FDA) has reviewed the protocol for this study under the Special Protocol Assessment (SPA) process. (salesandmarketingnetwork.com)

Some of these same types of health warnings exist for many of the foods consumers eat on a daily basis, including other forms of shellfish such as oysters and fish such as tuna and even salmon, if eaten in excess. (mainelobsterfestival.com)

One place where perchlorate occurs naturally is in saltpeter ` Eating food, including milk, contaminated with perchlorate. (cdc.gov)

LEXINGTON, Mass., June 30 (HSMN NewsFeed) -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV ) today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for NEBIDO related to a New Drug Application (NDA) submitted to the FDA in August 2007. (salesandmarketingnetwork.com)

The IRA aims to reduce the cost of prescription drugs for seniors through two key provisions. (americanactionforum.org)

Favorable tolerability enables potential expansion into autoimmune indications. (wkrn.com)
With 10 approved uses and the potential for more on the way, Humira (adalimumab) has emerged as the best-selling drug in the world. (drugwatch.com)

The Food and Agriculture Organization of the United States and the World Health Organization define probiotics as live microorganisms that, when ingested in an adequate amount, confer health benefit on the host. (medscape.com)

Lonafarnib is not approved for any indication, and is licensed from Merck Sharp & Dohme Corp. (known as MSD outside of the United States and Canada). (researchandmarkets.com)
State Street Corp increased its holdings in LifeMD by 8.2% during the 1st quarter. (defenseworld.net)

Data supporting the use of probiotics in this indication come from studies outside the United States and Canada, whereas two high-quality studies performed in those countries have shown no benefit. (medscape.com)

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. (mpg.de)

It is very gratifying to see that Max Planck spin-off company Alnylam succeded in bringing the first-ever RNAi-based drug to the market. (mpg.de)

The drug suppresses the immune system by blocking the activity of TNF. (drugwatch.com)

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Tumor1

Vaccine2

Evaluation2

Implications1

Substantial1

Dermatology1

Medical2

PrEP7

Biologics1

Currently approved1

Product4

Phase2

Medicines2

Include1

Kingdom1

Resistance1

Candidates1

Severe1

Amyloidosis2

Disease1

Continue1

Therapy1

Assessment1

Warnings1

Naturally1

Application1

Prescription1

Potential2

Health1

Corp2

Studies1

Development1

Company1

Immune1