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

Published on June 25, 2025 - 19:45 GMT

FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following ...

June 25, 2025 FDA Safety Communication Purpose: To inform the public and healthcare providers that FDA has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer Inc. and Spikevax (COVID- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 25, 2025 - 18:41 GMT

Drug Trials Snapshot: ALYFTREK

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 June 25, 2025 - 18:40 GMT

Drug Trials Snapshots: IOMERVU

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 June 24, 2025 - 21:20 GMT

FDA Investigating Deaths Due to Acute Liver Failure in Non-ambulatory Duchenne Muscular Dystrophy Patients Following ELEVIDYS

FDA Safety Communication – June 24, 2025 Summary of the Issue Since approval, the Food and Drug Administration (FDA) has received two reports of fatal acute liver failure following treatment of non-ambulatory pediatric male patients with Duchenne Muscular …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 24, 2025 - 20:32 GMT

www.peacefulmeds.com - 703470 - 05/05/2025

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

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 24, 2025 - 20:32 GMT

Sterling Distributors - 706508 - 06/05/2025

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Dean Berry Recipient Title President Sterling Distributors 4381 NW 124th Ave Coral Springs, FL 33065-7634 United States dberry@sterlingdistributors.net Issuing Office: Center for Drug …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 24, 2025 - 20:32 GMT

www.soma4ever.com - 706082 - 06/13/2025

Recipient: www.soma4ever.com Singapore Issuing Office: Center for Drug Evaluation and Research (CDER) United States TO: www.soma4ever.com FROM: The United States Food and Drug Administration RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

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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 …

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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 …

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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 …

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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