Docket Number: FDA-2018-D-0481 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or the Agency) is announcing the […]

Submit Comments by 02/04/2025 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 […]

On December 4, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not […]

On December 4, 2024, the Food and Drug Administration granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus N.V.) for adults with the following: advanced, unresectable, or metastatic […]

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 […]

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

For Immediate Release: December 03, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

What’s New iPLEDGE REMS Program for Isotretinoin Products The iPLEDGE Program was originally implemented in early 2005 and approved as the iPLEDGE REMS in 2010. The […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 24-HFD-45-11-01 Product: Drugs Recipient: Recipient Name Shoshana Shendelman, Ph.D. Recipient Title CEO & Founder Applied […]