On December 17, 2025, the Food and Drug Administration (FDA) approved rucaparib (Rubraca, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated […]

Historically, serious injuries and deaths have been associated with the use of contaminated heparin. FDA expects all imported heparin sodium lots to be compliant with the […]

By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of […]

Docket Number: FDA-2018-D-4726 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist applicants in preparing and submitting amendments […]

Summary Company Announcement Date: December 16, 2025 FDA Publish Date: December 16, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Product has been found […]

Summary Company Announcement Date: December 15, 2025 FDA Publish Date: December 16, 2025 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and […]

Reference #: FEI 3013712903 Product: Drugs Recipient: Recipient Name Dr. Sharvil Patel Recipient Title Managing Director Zydus Lifesciences Limited Zydus Corporate Park, S.G. HighwayNr. Vashnodevi CircleAhmedabad […]

Delivery Method: VIA UPS Reference #: 320-24-58 Product: Drugs Recipient: Recipient Name Dr. Sharvil Patel Recipient Title Managing Director Zydus Lifesciences Limited Zydus Corporate Park, S.G. […]

Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER December 12, 2025 RE: 719339 Musclepower Enterprise Ltd. dba MONSTER KING […]