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Latest posts
Last updated about 15 hours ago
Ongoing | Cancer Accelerated Approvals
about 20 hours ago
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications...
Compounding Inspections and Oversight Frequently Asked Questions
about 20 hours ago
Find answers to frequently asked questions regarding FDA’s inspections of compounding facilities...
FDA Roundup: April 23, 2024
about 20 hours ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...
FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF-altered pediatric low-grade glioma
about 21 hours ago
On April 23, 2024, the Food and Drug Administration granted accelerated approval...
FDA grants accelerated approval to tovorafenib for patient with relapsed or refractory BRAF-altered pediatric low-grade glioma
about 21 hours ago
On April 23, 2024, the Food and Drug Administration granted accelerated approval...
Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency
about 22 hours ago
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY...
FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS
about 24 hours ago
On April 23, 2024, the Food and Drug Administration approved lutetium Lu...
Compounding: Inspections, Recalls, and other Actions
about 24 hours ago
Human drug compounding; FDA inspections; compounding recalls
STOP CLOPEZ CORP Issues Voluntary Worldwide Recall of Schwinnng Capsules Due to the Presence of Undeclared Nortadalafil
1 day ago
Hollywood, FL, US, STOP CLOPEZ CORP is voluntarily recalling one lot of...