FDA Center for Drug Evaluation and Research - What's New 
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This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.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
FDA Roundup: February 13, 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 13, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma
On February 13, 2024, the Food and Drug Administration approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 13, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Synthetix Inc. DBA Helix Chemical Supply - 668918 - 02/07/2024
Unapproved New Drugs/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 13, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
US Chem Labs - 669074 - 02/07/2024
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 13, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Global Life Technologies Corp. - 674279 - 02/06/2024
Unapproved New Drugs/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 13, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
