388 NexiumNDA 021957 218948 Aurobindo Pharma Limited Esomeprazole Magnesium for Delayed-Release Oral Suspension, 5 mg 4/15/2025 No N/A N/A 387 NitroglycerinANDA 087355 218235 Encube Ethicals, Inc. […]

On April 23, 2025, the Food and Drug Administration approved penpulimab-kcqx (Akeso Biopharma Co., Ltd.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of […]

The Food and Drug Administration is advising consumers not to purchase or use Painflex Forte, a product promoted and sold for joint pain on various websites, […]

FDA has become aware of reports of adverse events involving compounded topical finasteride products potentially putting consumers at risk. The agency is aware of some compounders […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Arta Shaun Noorian Recipient Title Chief Executive Officer Empower Clinic Services, LLC dba Empower Pharma 5980 […]

Summary Company Announcement Date: April 18, 2025 FDA Publish Date: April 18, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Product may contain an […]

Date: May 15, 2025 Time: 9:00 a.m. – 4:30 p.m. ET Organized By: Contributor: Contributor After much consideration, we are postponing the Interested Parties Meeting: Implementation […]

Summary Company Announcement Date: October 31, 2023 FDA Publish Date: November 01, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Insanitary manufacturing conditions Company […]

FDA has reevaluated the rationale document entitled, “Piperacillin-Tazobactam Breakpoints for Pseudomonas aeruginosa” (MR15, January 2024), submitted by the Clinical and Laboratory Standards Institute (CLSI) to susceptibility […]