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

Published on September 23, 2025 - 15:12 GMT

Agebox iKids Growth Day Formula may be harmful due to hidden ingredient

[9-23-2025] The Food and Drug Administration is advising consumers not to purchase or use Agebox iKids Growth Day Formula, a product promoted and sold to stimulate growth and promote health in children ages five and older. Agebox iKids Growth Day Formula …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 23, 2025 - 15:12 GMT

Agebox iKids Growth Night Formula may be harmful due to hidden ingredient

[9-23-2025] The Food and Drug Administration is advising consumers not to purchase or use Agebox iKids Growth Night Formula, a product promoted and sold to stimulate growth and promote health in children ages five and older. Agebox iKids Growth Night …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 23, 2025 - 03:56 GMT

FDA use of Real-World Evidence in Regulatory Decision Making

CLOZARIL (clozapine) NDA 019758 Heritage Life Sciences (Barbados) c/o Heritage Life Sciences Therapeutics (USA) Veterans Health Administration (VHA) medical and pharmacy records Descriptive study In FDA’s review of the effectiveness of the clozapine …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 23, 2025 - 01:14 GMT

FDA Takes Action to Make a Treatment Available for Autism Symptoms

For Immediate Release: September 22, 2025 The U.S. Food and Drug Administration today initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that affects folate (a vitamin essential …

Distribution channels: Food & Beverage Industry

Published on September 23, 2025 - 01:14 GMT

FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy

FDA News Release Agency initiates safety label change and notifies physicians of possible link For Immediate Release: September 22, 2025 The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 22, 2025 - 12:59 GMT

Malaria: Developing Drugs for Treatment

Docket Number: FDA-2025-D-0918 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Malaria: Developing Drugs …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 21, 2025 - 20:40 GMT

Aquastar (USA) Corp Recalls Kroger Frozen Raw EZ Peel, Kroger Mercado Frozen Cooked Shrimp, and Aquastar Raw Shrimp Skewers ...

Summary Company Announcement Date: September 20, 2025 FDA Publish Date: September 21, 2025 Product Type: Food & Beverages Shellfish Contaminants Reason for Announcement: Recall Reason Description Due to possible radionuclide (Cesium-137) contamination …

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Published on September 20, 2025 - 22:04 GMT

Western United Fish Company Recalls Kirkland Signature Brand Ahi Tuna Wasabi Poke Because of Possible Health Risk

Summary Company Announcement Date: September 20, 2025 FDA Publish Date: September 20, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Product has the potential to be contaminated with Listeria …

Distribution channels: Food & Beverage Industry

Published on September 20, 2025 - 01:08 GMT

FDA Grants Accelerated Approval to First Treatment for Barth Syndrome

FDA News Release New Treatment for Barth Syndrome Showcases FDA’s Commitment to Bringing Effective and Safe Medications to Patients in Need For Immediate Release: September 19, 2025 Today, the U.S. Food and Drug Administration granted accelerated approval …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 19, 2025 - 19:41 GMT

FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection

On September 19, 2025, the Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 19, 2025 - 19:18 GMT

Goot Essa Recalls Der Mutterschaf Cheese 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 19, 2025 - 15:50 GMT

Olympus Issues Voluntary Recall for Specific Lots of ViziShot 2 FLEX (19G) EBUS -TBNA Needles

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 September 19, 2025 - 15:27 GMT

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Announcement - 10/09/2025

Date: October 9, 2025 Time: 8:30 a.m. - 6:00 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 19, 2025 - 01:54 GMT

Primal Herbs Volume may be harmful due to hidden drug ingredient

[9-18-2025] The Food and Drug Administration is advising consumers not to purchase or use Primal Herbs Volume, a product promoted and sold for sexual enhancement on various websites, including primalherbs.com, and possibly in some retail stores. FDA …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 18, 2025 - 14:11 GMT

Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act

Docket Number: FDA-2011-D-0164 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2025 - 23:03 GMT

Advancing Generic Drug Development: Translating Science to Approval - 09/21/2021

Advancing Generic Drug Development: Translating Science to Approval Keynote Address Janet Woodcock, MD Acting Commissioner of Food and Drugs Food and Drug Administration COVID-19 Impact on Generic Drug Regulation and Evaluation Protecting Participants …

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Published on September 17, 2025 - 23:03 GMT

FDA/Center for Research on Complex Generics (CRCG) Workshop on Modeling and Artificial Intelligence (AI) in Generic Drug ...

On This Page Date: October 15 - 16, 2025 Day1: Wed, Oct 15 8:30 a.m. - 05:00 p.m. ET Day2: Thu, Oct 16 8:30 a.m. - 03:40 p.m. ET Location: Event Location The Universities at Shady Grove Building II 9630 Gudelsky Drive Rockville, MD 20850 United States This …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2025 - 19:31 GMT

Haifa Smoked Fish Recalls “Cold Smoked Salmon” and “Cold Smoked Seabass” Due to 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 16, 2025 - 23:37 GMT

NuVida Medical LLC - 707745 - 09/04/2025

Delivery Method: Via UPS and EMAIL Reference #: CBER 25-707745 Product: Biologics Recipient: Recipient Name Park Thomas Recipient Title Chief Executive Officer and Owner NuVida Medical LLC 5814 S 25th St Phoenix, AZ 85040 United States park.thomas@ …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 16, 2025 - 23:37 GMT

CSL Behring - 716297 - 09/09/2025

Recipient: Recipient Name Kim Aubrey-Larcinese Recipient Title Senior Manager, Advertising & Promotion Global Regulatory Affairs CSL Behring 1020 First Avenue King of Prussia, PA 19406 United States Issuing Office: Center for Biologics Evaluation and …

Distribution channels: Healthcare & Pharmaceuticals Industry