Ojemda (tovorafenib) Patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 […]

What are the main differences between an FDA inspection of a 503A and 503B compounding facility? What is the difference between a surveillance inspection, a for-cause […]

For Immediate Release: April 23, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

The Brief Summary The Brief Summary is a quarterly bulletin intended for all OPDP stakeholders. Started in January 2022, The Brief Summary provides news and updates […]

On April 23, 2024, the Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age and […]

12/23/2023 East Fork Cultivars Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded 12/20/2023 Hua Da Trading, Inc. Center for Drug Evaluation and […]

Summary Company Announcement Date: April 23, 2024 FDA Publish Date: April 23, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Decreased Potency Company Name: […]

On April 23, 2024, the Food and Drug Administration approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric patients […]

A | B | C | D | E | F | G | H | I | J | K | L | M | […]