Generic Drugs Program Fiscal Year 2025 Activities Report
As outlined in the GDUFA III Commitment Letter, these performance metrics must be reported each fiscal year.Original and PAS ReviewGDUFA FY PerformanceReview Time GoalActions CompletedPercent on TimePotential RangeOn-Time Imminent ActionImminent Action Potential...FDA Qualifies First AI Drug Development Tool
[12/8/2025] The U.S. Food and Drug Administration (FDA) has qualified the first AI drug development tool, the AI-Based Histologic Measurement of NASH (AIM-NASH), to help pathologists assess metabolic dysfunction-associated steatohepatitis (MASH) disease activity in...OMISIRGE
STN: 125738Proper Name: omidubicel-onlvTradename: OMISIRGEManufacturer: Gamida Cell Ltd.Indication: For the treatment of:Adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following...FDA Approves First Generic Estradiol Vaginal Insert for Treatment of M
[December 8, 2025] The U.S. Food and Drug Administration today approved the first generic version of Imvexxy® (estradiol vaginal inserts). This approval will provide women additional options for access to treatment of moderate to severe dyspareunia (painful sexual...Mellace Family Brands California, Inc. Recalls Wegmans Deluxe Mixed Nuts Unsalted, 34 oz and 11.5 oz Packages Because Of Possible Health Risk
Summary Company Announcement Date: December 05, 2025 FDA Publish Date: December 05, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Product may be contaminated with Salmonella Company Name: Mellace Family Brands California,...All Drug Purchases Are
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