Drug approvals, label changes, and FDA drug news.
The mission of the Office of Pharmaceutical Quality is to assure that quality medicines are available to the American public. The annual Report on the State of Pharmaceutical Quality is intended to help characterize the quality of the U.S. drug supply chain. Learn more.
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Merz Pharms
FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer
Learn about the warnings for sleep, skin and bodybuilding products that contain hidden drugs and other hidden ingredients.
The Food and Drug Administration is advising consumers not to purchase or use PRE-FORMANCE BLACK, a product promoted to boost energy and increase performance on various websites, including Advancedsupps.com, and possibly in some retail stores.
The U.S. Food and Drug Administration (FDA) has approved Tryngolza (olezarsen), used with diet, to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia.
On June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer follo
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Immunomedics Inc
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Immunomedics Inc
Efficacy supplement (new or revised indication). solution, subcutaneous. Sponsor: Ionis Pharms Inc
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Merck Sharp Dohme
Efficacy supplement (new or revised indication). capsule, oral. Sponsor: Pfizer
Efficacy supplement (new or revised indication). tablet, oral. Sponsor: Pfizer
Efficacy supplement (new or revised indication). solution, intravenous. Sponsor: Merck Sharp Dohme
Original new drug approval. powder, intravenous. Sponsor: Avyxa Holdings
This webpage provides an overview of investigational new drug application (IND) safety reporting requirements for sponsors set forth in 21 CFR 312.32 and additional resources, including FDA guidances, related to these requirements.
The U.S. Food and Drug Administration has approved the first generic of Priftin (rifapentine) tablets, a medication for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more antituberculosis drugs.
Explore the FDA’s Competitive Generic Therapy Approvals page, offering insights into the program designed to encourage generic drug competition. Access information about approved CGT products and find resources, including a downloadable CGT approvals spreadsheet.
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.
Monthly and quarterly metrics of the FDA Generic Drugs Program.
Learn more about actions to accelerate and modernize clinical research across the full continuum of drug development —from the Investigational New Drug (IND) phase to late-stage pivotal trials.
The Phase 1 IND Navigator provides the tools, guidances, and regulatory expertise you need to prepare and submit an successful Investigational New Drug (IND) application.
Information on Federal Regulations related to Phase 1 INDs