U.S. Food and Drug Administration Press Releases

• Published on September 26, 2025 - 15:35 GMT

  

  Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned - 09/23/2025

  Speech by Sara Brenner, M.D., M.P.H. Principal Deputy Commissioner - Office of the Commissioner Good morning, and thank you for being here. At FDA, our work is guided by two principles: application of common-sense approaches to problem solving and …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 26, 2025 - 14:54 GMT

  

  Georgia Nut Company (GNC), Third-Party Manufacturer for Tru Fru, LLC Issues Voluntary Recall of Specific Varieties of Tru Fru ...

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels: Food & Beverage Industry
• Published on September 25, 2025 - 21:23 GMT

  

  ABECMA

  STN: BLA 125736 Proper Name: Idecabtagene Vicleucel Tradename: ABECMA Manufacturer: Celgene Corporation, a Bristol-Myers Squibb Company Indications: Treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 25, 2025 - 19:33 GMT

  

  FDA approves imlunestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

  On September 25, 2025, the Food and Drug Administration approved imlunestrant (Inluriyo, Eli Lilly and Company), an estrogen receptor antagonist, for adults with estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative, estrogen …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 25, 2025 - 18:42 GMT

  

  FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)

  FDA News Release Agency determines special restrictions are no longer necessary to ensure the benefits of thyroid cancer treatment with Caprelsa outweigh its risks For Immediate Release: September 25, 2025 The U.S. Food and Drug Administration today …

  Distribution channels: Food & Beverage Industry
• Published on September 25, 2025 - 18:42 GMT

  

  FDA Authorizes Marketing of First Eyeglass Lenses to Slow Progression of Pediatric Myopia

  For Immediate Release: September 25, 2025 Today, the U.S. Food and Drug Administration authorized marketing of the Essilor Stellest eyeglass lenses to correct myopia, commonly referred to as nearsightedness, with or without astigmatism and to slow the …

  Distribution channels: Food & Beverage Industry
• Published on September 25, 2025 - 14:25 GMT

  

  Tarmac Products, Inc. - 595993 - 11/09/2020

  Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Adalberto Cabrera Recipient Title Chief Operating Officer Tarmac Products, Inc. 16311 NW 52nd Avenue Miami Gardens, FL 33014 United States acabrera@tarmac-usa.com Issuing Office: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 25, 2025 - 14:25 GMT

  

  Tarmac Products, Inc. - 595993 - 09/18/2025

  Reference #: FEI 1025483 Product: Drugs Recipient: Recipient Name Mr. Adalberto R. Cabrera Recipient Title Chief Operating Officer Tarmac Products, Inc. 16311 NW 52nd AVE Miami Gardens, FL 33014-6209 United States Issuing Office: Division of Medical Device …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 24, 2025 - 18:18 GMT

  

  PDUFA VII Commitment: An Assessment of the Sentinel System (2022 to 2024)

  One of the areas FDA is committed to enhancing and modernizing is the FDA drug safety system, in part through the optimization of the Sentinel Initiative. FDA has a series of commitments under PDUFA VII to maintain Sentinel Initiative capabilities and …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 24, 2025 - 13:10 GMT

  

  Media Networks Sydney Pty. Limited - 711342 - 09/16/2025

  Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-110 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Gilad Wielunski Media Networks Sydney Pty. Limited 36 Mid Dural Rd. Galston NSW 2159 Australia Issuing Office: Center …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 24, 2025 - 12:59 GMT

  

  Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

  Docket Number: FDA-2017-D-6159 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research, Office of Therapeutic Products This guidance provides sponsors engaged in the development of regenerative medicine therapies for serious or life …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 24, 2025 - 12:58 GMT

  

  Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products

  Docket Number: FDA-2017-D-6159 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research, Office of Therapeutic Products The purpose of this guidance is to discuss methods and approaches for capturing postapproval safety and efficacy …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 24, 2025 - 12:58 GMT

  

  Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations

  Docket Number: FDA-2025-D-3403 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research, Office of Therapeutic Products This guidance provides recommendations to sponsors who are planning clinical trials of cell and gene therapy (CGT …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 24, 2025 - 03:25 GMT

  

  Sprout Organics Expands Voluntary Recall of Sweet Potato Apple and Spinach to Include Additional Lot Codes

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels: Food & Beverage Industry
• Published on September 24, 2025 - 03:25 GMT

  

  Lawrence Wholesale LLC Recalls Kroger Bagged Frozen Shrimp and Kroger Frozen Shrimp Products Because of Possible Health Risk

  Summary Company Announcement Date: September 23, 2025 FDA Publish Date: September 23, 2025 Product Type: Food & Beverages Shellfish Contaminants Reason for Announcement: Recall Reason Description Due to possible radionuclide (Cesium-137) contamination. …

  Distribution channels: Food & Beverage Industry
• Published on September 23, 2025 - 22:36 GMT

  

  Flexi Bion may be harmful due to hidden drug ingredients

  [9-23-2025] The Food and Drug Administration is advising consumers not to purchase or use Flexi Bion, a product promoted and sold for joint pain on various websites, including ebay.com, and possibly in some retail stores. FDA laboratory analysis confirmed …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 23, 2025 - 20:33 GMT

  

  Piperacillin – Injection Products

  For the bacteria listed below, susceptibility test interpretive criteria are not recognized at this time: Other Non-Enterobacterales

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 23, 2025 - 18:48 GMT

  

  AquaStar (USA) Corp Recalls AquaStar Raw Shrimp Skewers Because of Possible Health Risk

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels: Food & Beverage Industry
• Published on September 23, 2025 - 16:56 GMT

  

  Cellebration LLC - 713252 - 09/12/2025

  Delivery Method: VIA UPS and Electronic Mail Reference #: CBER 25-713252 Product: Biologics Recipient: Recipient Name George Kaltner Recipient Title Chief Executive Officer and President Cellebration LLC (b)(6) San Juan 00909 Puerto Rico george@ …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 23, 2025 - 16:56 GMT

  

  General Principles of Software Validation

  Docket Number: FDA-1997-D-0029 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health This guidance outlines general validation principles that the Food and Drug Administration (FDA) …

  Distribution channels: Healthcare & Pharmaceuticals Industry