U.S. Food and Drug Administration Press Releases - EIN Presswire

Published on October 29, 2025 - 00:16 GMT

POSTPONED - 17th Annual Sentinel Initiative Public Workshop - 11/06/2025

On This Page Date: November 6, 2025 Time: 9:00 a.m. - 3:00 p.m. ET Location: Event Location FDA Headquarters FDA White Oak Campus 10903 New Hampshire Ave, Building 31 The Great Room Silver Spring, MD 20903 United States The 17th Annual Sentinel Initiative …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 28, 2025 - 20:42 GMT

Purity Products Announces Recall on the Dietary Supplement, My Bladder 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 October 28, 2025 - 14:47 GMT

The Tranzonic Companies/Innocore Sales & Marketing Inc. - 712258 - 10/16/2025

Delivery Method: Via Electronic Mail - Delivery and Read Receipt Requested Reference #: 320-26-07 Product: Drugs Recipient: Recipient Name Mr. Robert Kibbe Recipient Title President and CEO The Tranzonic Companies/Innocore Sales & Marketing Inc. 26301 …

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Published on October 27, 2025 - 18:45 GMT

Peterson Company Recalls Twin Sisters Creamery Brand Whatcom Blue and Farmhouse Cheese Products 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 October 25, 2025 - 04:00 GMT

Teasdale Latin Foods Issues Allergy Alert on Potential Undeclared Milk in Certain Taco Dinner Kits

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 October 25, 2025 - 04:00 GMT

E.A. Sween Company Announces Product Recall Due to Choking Hazard

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 October 24, 2025 - 20:08 GMT

FDA approves revumenib for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation

On October 24, 2025, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 24, 2025 - 04:00 GMT

Zingerman’s Candy Manufactory Issues Allergy Alert on Undeclared Peanut & Cashew in Candy Bars

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 October 23, 2025 - 18:33 GMT

2024 First Generic Drug Approvals

76 218492 Prucalopride Tablets Novitium Pharma LLC Motegrity Tablets 12/26/2024 For the treatment of chronic idiopathic constipation in adults 75 215971 Deutetrabenazine Tablets Aurobindo Pharma Limited Austedo Tablets 12/26/2024 For the treatment in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 23, 2025 - 16:38 GMT

Drug recall information for consumers, health care professionals and industry

FDA’s role in drug recalls A recall may be recommended or requested by FDA or initiated voluntarily at any time by a company. FDA’s role in a recall is to oversee a company’s recall strategy and ensure adequate steps were taken to implement the recall. FDA …

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Published on October 23, 2025 - 15:35 GMT

FDA Publishes Filing Checklists to Prevent Submission Delays

For Immediate Release: October 23, 2025 The U.S. Food and Drug Administration today made public filing checklists used internally by Center for Drug Evaluation and Research (CDER) staff to determine if a submitted application is complete and reviewable. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 23, 2025 - 13:12 GMT

FDA Rationale for Recognition Decision: Gentamicin, Tobramycin, and Amikacin for Enterobacterales and P. aeruginosa

FDA has completed its review of the rationale document titled, “Aminoglycoside Breakpoints for Enterobacterales and Pseudomonas aeruginosa” submitted by the Clinical and Laboratory Standards Institute (CLSI) to the public docket FDA-2017-N-5925-0037 in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 23, 2025 - 13:12 GMT

Fosfomycin Injection

S = Susceptible; I = Intermediate; R = Resistant a. Susceptibility interpretive criteria are based on a dose of 6 grams fosfomycin every 8 hours by intravenous infusion over 1 hour in patients with an estimated creatinine clearance of 50 mL/min. b. For …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 22, 2025 - 19:21 GMT

Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments

Docket Number: FDA-2022-D-1385 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health FDA is posting this document to provide advance notice to the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 22, 2025 - 19:21 GMT

Completed BsUFA II Deliverables

Best Practices for Communication Between IND Sponsors and FDA During Drug Development Final Guidance Updated guidance on best practices for communication between IND sponsors and FDA during drug development. Meeting Management Goals 12/29/2017 BsUFA II: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 21, 2025 - 19:09 GMT

FDA Provides Update to Health Care Professionals About Risk of Inadvertent Intrathecal (Spinal) Administration of Tranexamic Acid ...

FDA is requiring labeling changes to strengthen the warnings that tranexamic acid injection should be administered only intravenously (into the vein). Tranexamic acid injection products are not to be administered intrathecally (into the spine) or as an …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 21, 2025 - 19:09 GMT

MOLOOCO dba Ourlyard - Online Advisory Letter

Online Advisory Letter Reference #715639 September 8, 2025 MOLOOCO dba Ourlyard payments@mooloco.com RE: DoubleNano Advanced Lung Detox Relief Patch To whom it may concern: This letter is to advise you that the U.S. Food and Drug Administration (FDA) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 21, 2025 - 17:20 GMT

www.usmedschoice.com - 716055 - 10/06/2025

Recipient: www.usmedschoice.com United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States FROM: The United States Food and Drug Administration RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 21, 2025 - 17:20 GMT

All American Wellness - 715991 - 09/09/2025

Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Product: Drugs WARNING LETTER September 9, 2025 All American Wellness: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 21, 2025 - 17:20 GMT

Foshan Yiying Hygiene Products Co., Ltd. - 715548 - 10/10/2025

Delivery Method: VIA Electronic Mail Reference #: 320-26-04 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Veblen Liang Recipient Title General Manager Foshan Yiying Hygiene Products Co., Ltd. Industrial Building No. 3, Ruichang …

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