FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 16, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Roundup: February 16, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 16, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access - 04/10/2024
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 16, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Trials Snapshots: AGAMREE
AGAMREE is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 16, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure
The FDA approved a new medication for the reduction of allergic reactions that may occur with accidental exposure to one or more foods. Patients who take this medication must continue to avoid foods they are allergic to. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 16, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves tepotinib for metastatic non-small cell lung cancer
On February 15, 2024, the Food and Drug Administration granted traditional approval to tepotinib (Tepmetko, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Ongoing Clinical Oncology Projects
Clinical projects of the Oncology Center of Excellence, 2023 Annual Report (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Trials Snapshots: BIMZELX
BIMZELX is an anti-interleukin (IL)-17A and IL-17F monoclonal antibody that is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Ongoing Clinical Oncology Projects
Clinical projects of the Oncology Center of Excellence, 2023 Annual Report (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Professional Education and Resources
Oncology Center of Excellence professional education projects and resources - 2023 OCE Annual Report (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Oncology Regulatory Review 2023
Oncology Regulatory Review section of the Oncology Center of Excellence 2023 Annual Report (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Trials Snapshots: BEYFORTUS
BEYFORTUS is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Education Efforts to Help Increase Biosimilar Understanding and Acceptance
A spotlight on CDER's numerous education outreach efforts to promote biosimilar acceptance and use. The piece features descriptions of educational content on the FDA website, Reddit AMAs, Google/YouTube ads, PSAs, and other resources that are available to the public. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 14, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves First Medication to Treat Severe Frostbite
The FDA approved an injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 14, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Charging for Investigational Drugs Under an IND: Questions and Answers
; Guidance for Industry (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 14, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news