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

Published on May 22, 2025 - 13:42 GMT

Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC - 654751 - 05/19/2025

Delivery Method: Via Email Reference #: 2851, CMS 654751 Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices Dear Kunjal Joshi: The Food and Drug Administration has completed an evaluation …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 22, 2025 - 13:06 GMT

New Grains Gluten Free Bakery Issues Allergy Alert on Undeclared Eggs, Tree Nuts, Soy, and Milk in Bakery Products

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 May 20, 2025 - 22:55 GMT

Bedner Growers, Inc. Recalls Cucumbers 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 May 20, 2025 - 18:26 GMT

NWL Netherlands Services B.V. - 701206 - 04/01/2025

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-59 Product: Drugs Recipient: Recipient Name Mr. Jimmy Duivenvoorden Recipient Title Site Manager NWL Netherlands Services B.V. Amperestraat 12 Hillegom 2181 HB Zuid-Holland Netherlands Jimmy. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 20, 2025 - 18:26 GMT

Product Society LLC - 702927 - 05/08/2025

Delivery Method: VIA UPS Reference #: 320-25-71 Product: Drugs Recipient: Recipient Name Mr. Phillip A.S. Miller Product Society LLC 13056 Saticoy Street North Hollywood, CA 91605 United States Issuing Office: Center for Drug Evaluation and Research (CDER) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 20, 2025 - 18:26 GMT

Sarfez Pharmaceuticals, Inc. - 708901 - 04/25/2025

Recipient: Recipient Name Salim Shah, PhD, JD Recipient Title Founder/President/CEO Sarfez Pharmaceuticals, Inc. 8000 Towers Crescent Drive Suite 1302 Vienna, VA 22182 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 20, 2025 - 17:12 GMT

Supreme Rejuvenation, LLC - 700749 - 05/05/2025

Delivery Method: VIA UPS and Electronic Mail Reference #: CBER 25-700749 Product: Biologics Recipient: Recipient Name Aracely Cabrera Recipient Title Chief Executive Officer Supreme Rejuvenation, LLC 11861 S Sam Houston Parkway, Suite A Houston, TX 77031 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 20, 2025 - 17:12 GMT

United Health Products, Inc. - 697777 - 03/24/2025

Product: Biologics Medical Devices Recipient: Recipient Name Brian Thom United Health Products, Inc. 520 Fellowship Road, Suite #D-406 Mt. Laurel, NJ 08054 United States (b)(6)@uhpcorp.com Issuing Office: Center for Devices and Radiological Health United …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 20, 2025 - 17:11 GMT

Skye Biologics Holdings LLC - 654466 - 12/16/2024

Delivery Method: VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED Reference #: CBER-24-654466 Product: Biologics Recipient: Recipient Name Christopher M.B. Sharp Recipient Title Chief Executive Officer Skye Biologics Holdings LLC 2255 Campus Dr El Segundo, CA …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 19, 2025 - 20:32 GMT

R&M Trading LLC Issues Allergy Alert on Undeclared Milk in R&M Refresher Instant Milk Tea Powder

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 May 19, 2025 - 03:23 GMT

NUVAXOVID

STN: 125817 Proper Name: COVID-19 Vaccine, Adjuvanted Tradename: NUVAXOVID Manufacturer: Novavax, Inc. Indication: NUVAXOVID is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 16, 2025 - 20:33 GMT

FDA to Host Inaugural, Independent, Scientific Expert Panel Open to Public

For Immediate Release: May 16, 2025 As part of the Trump Administration’s commitment to transform American health care and rebuild trust in public health, the U.S. Food and Drug Administration’s Commissioner Martin A. Makary, M.D., M.P.H., will lead a …

Distribution channels: Food & Beverage Industry

Published on May 16, 2025 - 20:33 GMT

FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease

For Immediate Release: May 16, 2025 The U.S. Food and Drug Administration today cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for …

Distribution channels: Food & Beverage Industry

Published on May 16, 2025 - 20:03 GMT

South Asian Food Inc. Issues Allergy Alert on Undeclared Peanuts in "Bengal King Family Pack Vegetable Singara"

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 …

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Published on May 15, 2025 - 23:14 GMT

FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal

On May 15, 2025, the Food and Drug Administration approved retifanlimab-dlwr (Zynyz, Incyte Corporation) with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 15, 2025 - 19:06 GMT

FDA Rationale for Recognition Decision: Amoxicillin and Clavulanate against Haemophilus influenzae

FDA has reevaluated data supporting amoxicillin/clavulanate breakpoints against Haemophilus influenzae. The review included a publication describing the Clinical and Laboratory Standards Institute (CLSI) rationale for revision of the amoxicillin/ …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 15, 2025 - 19:06 GMT

Nana Barseghian, M.D. - 708009 - 04/28/2025

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-04-01 Product: Drugs Recipient: Nana Barseghian, M.D. 19875 Nordhoff Street Northridge, CA 91324 United States Issuing Office: Center for Drug Evaluation and Research (CDER) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 14, 2025 - 18:14 GMT

FDA approves belzutifan for pheochromocytoma or paraganglioma

On May 14, 2025, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). This …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 13, 2025 - 19:11 GMT

FDA 101: Product Recalls

Image What Is a Recall? A recall is an action taken by a company to correct or remove from the market an FDA regulated product that violates U.S. laws and regulations. Recalls may be initiated voluntarily by a company, or at the request of the FDA. Recalls …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 13, 2025 - 15:46 GMT

FDA Begins Action To Remove Ingestible Fluoride Prescription Drug Products for Children from the Market

For Immediate Release: May 13, 2025 The U.S. Food and Drug Administration (FDA) today announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market. Unlike toothpaste with fluoride …

Distribution channels: Food & Beverage Industry