On This Page Date: September 18, 2025 Time: 9:00 a.m. – 3:00 p.m. ET Under the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]

Based on a new analysis of human pregnancy data compiled from the use of endothelin receptor antagonist (ERA) medicines for two decades, FDA has determined that […]

Delivery Method: Via Email Reference #: 320-25-88 Product: Drugs Recipient: Recipient Name Phanesh Koneru, PhD, LL.M. Recipient Title President and CEO Exela Pharma Sciences, LLC 1245 […]

On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced […]

AUDIENCE: Patient, Health Care Professional, Pharmacy, Pediatrics ISSUE: The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) – including […]

On July 2, 2025, the Food and Drug Administration granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

Submit Comments by 09/01/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]