Drug approvals, label changes, and FDA drug news.
For 120 years the FDA's public health priorities have remained rooted in the same enduring mission. Today we are articulating our priorities in a way that reflects the scientific, technological and geopolitical reality shaping this new era of innovation as well as the future of public health.
Join SBIA as FDA shares the latest updates on registration and listing submissions, including current validation rules, and walks through the evolving regulatory requirements and compliance framework that shape how industry engages with these processes.
Dissemination of pediatric information resulting from pediatric studies done pursuant to FDAAA
Original new drug approval. tablet, oral. Sponsor: Msd
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been granted for supportive care products and changes to dosing or formulation.
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication.
C. A. Snyder et al.
Learn about the warnings for pain and arthritis products that contain hidden drugs and other hidden ingredients.
The Food and Drug Administration is advising consumers not to purchase or use Xian Ling, a product promoted and sold for pain on various websites and in some retail stores.
FDA is advising consumers not to purchase or use Tawon Liar, a product promoted and sold for pain, rheumatism, insomnia, improving the immune system, increasing energy, and lowering cholesterol on various websites, including www.etsy.com, and possibly in some retail stor
Learn more about recent news and events related to rare diseases and read ARC Program Annual Reports.
Learn about the warnings for weight loss products that contain hidden drugs and other hidden ingredients.
The U.S. Food and Drug Administration approved the first generic versions of GILOTRIF (afatinib tablets) for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-a
On July 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic bre
FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors
The FDA has approved a new small molecule inhibitor from Celcuity with blockbuster potential that could become a new standard-of-care for patients with breast cancer.
Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Efficacy supplement (new or revised indication). capsule, oral. Sponsor: Eli Lilly And Co
Original new drug approval. powder, intravenous. Sponsor: Celcuity
Efficacy supplement (new or revised indication). capsule, oral. Sponsor: Eli Lilly And Co
7-OH: Emergence of a Fourth Opioid Epidemic
FDA notifications for industry on data integrity.
The U.S. Food and Drug Administration (FDA) has approved a new starting dosage regimen for the subcutaneous (under the skin) formulation of Leqembi (lecanemab-irmb), an amyloid beta-directed antibody indicated for the treatment of adult patients with Alzheimer's disease.