U.S. Food and Drug Administration Press Releases

• Published on August 19, 2025 - 01:32 GMT

  

  Approaches to Assessment of Overall Survival in Oncology Clinical Trials

  Submit Comments by 10/20/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 18, 2025 - 23:42 GMT

  

  Middlefield Original Cheese Co-Op Recalls 100% Grass-Fed Pepper Jack Cheese and Horseradish Flavored Cheese Due to Possible ...

  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 August 18, 2025 - 17:02 GMT

  

  Patient-Focused Drug Development: Workshop #2 to Discuss Methodologic and Other Challenges Related to Patient Experience Data - 09/...

  On This Page Date: September 18 - 19, 2025 Day1: Thu, Sep 18 12:30 p.m. - 05:00 p.m. ET Day2: Fri, Sep 19 12:30 p.m. - 04:00 p.m. ET On September 18 and 19, 2025, the U.S. Food and Drug Administration (FDA) is hosting a virtual public workshop to discuss …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 18, 2025 - 13:32 GMT

  

  Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development

  Submit Comments by 10/20/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 18, 2025 - 11:54 GMT

  

  Drug Trials Snapshots: ENFLONSIA

  HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 15, 2025 - 21:54 GMT

  

  Public Notification: Green Lumber contains hidden drug ingredient

  [8-13-2025] FDA continues to advise consumers not to purchase or use the Green Lumber Natural Fuel For Men product. FDA laboratory analysis confirmed that additional versions of the Green Lumber product sold by Green Lumber Holdings LLC contain tadalafil.  …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 15, 2025 - 21:53 GMT

  

  BK251199 - NLF system® kit 2 (EUROMI)

  The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 15, 2025 - 16:45 GMT

  

  Drug Trials Snapshot: TRYPTYR

  HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 15, 2025 - 16:45 GMT

  

  Drug Trials Snapshots: EMRELIS

  HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 15, 2025 - 00:29 GMT

  

  FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis

  For Immediate Release: August 14, 2025 Today, the U.S. Food and Drug Administration approved Papzimeos (zopapogene imadenovec-drba), a first-of-its-kind non-replicating adenoviral vector-based immunotherapy for the treatment of adult patients with …

  Distribution channels: Food & Beverage Industry
• Published on August 14, 2025 - 23:57 GMT

  

  Fromi USA Recalls Brie Royal Faucon 1kg 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 Summary Company …

  Distribution channels: Food & Beverage Industry
• Published on August 14, 2025 - 14:56 GMT

  

  Understanding FDA Terms for Possible New Therapies to Prevent and Treat Diseases

  Image The U.S. Food and Drug Administration is responsible for protecting the public health by, among other things, ensuring the safety and effectiveness of drugs, biological products and medical devices. In certain circumstances, the FDA allows the …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 14, 2025 - 14:50 GMT

  

  Pediatric Anesthesia

  Millions of children receive anesthesia and sedation drugs each year for surgeries and procedures; however, until recently, little was known about these drugs’ effects on the developing brain. Research studies have found that early exposure in juvenile …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 14, 2025 - 14:50 GMT

  

  Lessons Learned From the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program - 09/10/2025

  On This Page Date: September 10, 2025 Time: 1:00 p.m. - 5:00 p.m. ET FDA and the Duke-Margolis Institute for Health Policy will host a virtual workshop on September 10, 2025  that will delve into the challenges and strategies for expedited chemistry, …

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• Published on August 13, 2025 - 18:59 GMT

  

  Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products

  For Immediate Release: August 13, 2025 Statement From: Martin A Makary, M.D., M.P.H. Commissioner of Food and Drugs - Food and Drug Administration Today I applaud Florida Attorney General James Uthmeier’s bold efforts to protect Floridians by filing an …

  Distribution channels: Food & Beverage Industry
• Published on August 13, 2025 - 18:17 GMT

  

  Quesito El Establo Retira Del Mercado Queso (Quesito Colombiano) Debido a Posible Riesgo Para La Salud

  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 …

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• Published on August 13, 2025 - 14:27 GMT

  

  Pediatric Developmental Safety Assessment: New Approach Methods - 12/05/2025

  On This Page Date: December 5, 2025 Time: 8:00 a.m. - 4:00 p.m. ET Location: Event Location FDA, White Oak Campus, The Great Room Building 31 10903 New Hampshire Avenue Silver Spring, MD 20903 United States This meeting comes at a critical time for …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 13, 2025 - 02:05 GMT

  

  Quesito El Establo Recalls Spanish Cheese (Quesito Colombiano) 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 …

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• Published on August 13, 2025 - 00:43 GMT

  

  Max Mobility / Permobil Announces Worldwide Expanded Recall and Removal of all SpeedControl Dials from the Market Due to ...

  Summary Company Announcement Date: August 12, 2025 FDA Publish Date: August 12, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to potential safety and performance concerns Company Name: Max Mobility, LLC. Brand …

  Distribution channels: Food & Beverage Industry
• Published on August 13, 2025 - 00:43 GMT

  

  Dollar General Announces Voluntary Recall of Clover Valley® Instant Coffee Due to Potential Presence of Glass

  Summary Company Announcement Date: August 11, 2025 FDA Publish Date: August 12, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential presence of glass Company Name: Dollar General Corporation Brand Name: …

  Distribution channels: Food & Beverage Industry