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

Published on June 24, 2025 - 20:32 GMT

Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi - 709156 - 06/16/2025

Delivery Method: VIA Electronic Mail Reference #: 320-25-82 Product: Drugs Recipient: Recipient Name Mr. Sinan Gundogan Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi Erbay Center IC Kapi No.11 No.4 Mahmutbey Mahallesi Haci Bostan Caddesi …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 24, 2025 - 20:32 GMT

Toki Slimming Candy may be harmful due to hidden drug ingredients

Toki Slimming Candy The Food and Drug Administration is advising consumers not to purchase or use Toki Slimming Candy, a product promoted and sold for weight loss on various websites, including www.eBay.com, and possibly in some retail stores. FDA …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 23, 2025 - 21:30 GMT

FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer

On June 23, 2025, the Food and Drug Administration granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 23, 2025 - 14:02 GMT

Q1 Stability Testing of Drug Substances and Drug Products

Docket Number: FDA-2025-D-1106 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for …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 June 21, 2025 - 22:44 GMT

Face Rock Creamery Voluntarily Recalls Vampire Slayer Garlic Cheddar Curds 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 June 21, 2025 - 03:02 GMT

International Foodsource, LLC. Issues Allergy Alert in Nonpareil, Semi-Sweet Chocolate (Christmas Seeds) Sold as Dark Chocolate ...

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 June 21, 2025 - 03:02 GMT

Sabores Bakery, Dba Sabores A Tu Mesa, Issues Allergy Alert on Undeclared Milk in Mousse Desserts

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 June 20, 2025 - 20:34 GMT

Lipari Foods Issues Allergy Alert on Undeclared Milk in "Dark Chocolate Nonpareils"

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 June 20, 2025 - 19:25 GMT

Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication - FDA Adds Warning About Serious Risk of Heat-Related ...

The patch can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases AUDIENCE: Patient, Health Care Professional, Neurology ISSUE: The FDA is warning that the antinausea patch Transderm Scōp …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 19, 2025 - 03:07 GMT

PRIVIGEN

STN: 125201 Proper Name: Immune Globulin Intravenous (Human), 10% Liquid Tradename: PRIVIGEN Manufacturer: CSL Behring AG Indication: For the treatment of: Primary humoral immunodeficiency (PI) Chronic immune thrombocytopenic purpura (ITP) in patients age …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 18, 2025 - 23:53 GMT

FDA Halts New Clinical Trials That Export Americans’ Cells to Foreign Labs in Hostile Countries for Genetic Engineering

For Immediate Release: June 18, 2025 The U.S. Food and Drug Administration (FDA) today announced an immediate review of new clinical trials that involve sending American citizens’ living cells to China and other hostile countries for genetic engineering …

Distribution channels: Food & Beverage Industry

Published on June 18, 2025 - 20:19 GMT

FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma

On June 18, 2025, the Food and Drug Administration approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL). Full prescribing information for Monjuvi will be …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 18, 2025 - 19:46 GMT

Weaver Nut Company Inc., Issues Allergy Alert on Undeclared Milk in Chocolate Nonpareils

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 June 18, 2025 - 16:35 GMT

Medtech Products Inc. Issues Nationwide Recall of Little Remedies® Honey Cough Syrup Due to Microbial Contamination

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 June 18, 2025 - 15:35 GMT

FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Scōp (scopolamine transdermal ...

Through August 16, 2024, FDA identified 13 cases worldwide, including 7 in the United States, of hyperthermia associated with scopolamine patches from the FDA Adverse Event Reporting System (FAERS) database, biomedical literature, manufacturer-submitted …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 18, 2025 - 00:30 GMT

Xenotransplantation Guidances

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Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 17, 2025 - 22:03 GMT

July 18, 2025: Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement - 07/18/2025

Date: July 18, 2025 Time: 9:00 a.m. - 4:00 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 June 17, 2025 - 22:02 GMT

2025 Meeting Materials, Psychopharmacologic Drugs Advisory Committee

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Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 17, 2025 - 18:50 GMT

Allergenics Guidances

Image Should you find a link that does not work within any Guidance document, Rule or other document posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact FDA. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 17, 2025 - 15:14 GMT

FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests

For Immediate Release: June 17, 2025 The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug developers to …

Distribution channels: Food & Beverage Industry