Product: Drugs Recipient: Ozempen.com United States Issuing Office: Center for Drug Evaluation and Research | CDER United States FROM: The United States Food and Drug Administration […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Product: Drugs Recipient: Recipient Name Mr. Dilip Shanghvi Recipient Title Managing Director Sun Pharmaceutical Industries Limited Sun House, Plot […]

This web page provides information about the in vitro susceptibility of fungi to certain drugs. The safety and efficacy of these drugs in treating clinical infections due […]

Alecensa (alectinib) capsules Alunbrig (brigatinib) tablets Lorbrena (lorlatinib) tablets Zykadia (ceritinib) capsules; tablets Optic neuropathy FDA is evaluating the need for regulatory action. Antidepressants Selective serotonin […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Mingzhong Su Recipient Title President Sani-Care Salon Products, Inc. 51 Curtis Court, Ste. BCartersville, GA […]

On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as […]

For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of […]

On March 28, 2025, the Food and Drug Administration expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) to include adults with […]

[03/28/2025] FDA has identified significant data integrity and study conduct concerns with bioequivalence studies conducted by Raptim Research Pvt. Ltd., a contract research organization (CRO) based […]