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 […]

FDA is committed to continuing to work with states and Indian tribes that seek to develop an importation proposal under section 804 of the Federal Food, […]

Docket Number: FDA-2022-D-2301 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-06-01 Product: Drugs Recipient: Recipient Name Peter Michael, M.D. “Peter Michael, M.D. 1401 East 4th […]