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

Published on August 12, 2025 - 13:46 GMT

Eco-NAMs Webinar Series | State of the Science for Bioaccumulation: An Integrated, Weight of Evidence Approach - 09/10/2025

On This Page The Eco-NAMS webinar series is co-organized by the U.S. Food and Drug Administration, U.S. Environmental Protection Agency, European Medicines Agency, Health and Environmental Sciences Institute, National Institute for Environmental Studies ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 12, 2025 - 13:46 GMT

Confer With - 707691 - 08/01/2025

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Serge Milbank Confer With 81 Rivington St London EC2A 3AY United Kingdom getintouch@conferwith.io Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 12, 2025 - 13:46 GMT

Vacation Inc. - 706039 - 08/06/2025

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name James Dakota Green Vacation Inc. 936 SW 1st Ave #888 Miami, FL 33130 United States vacation@vacation.inc Issuing Office: Center for Drug Evaluation and Research (CDER) United States …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 12, 2025 - 13:46 GMT

Kalani AB dba Kalani Sunwear - 710998 - 08/06/2025

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Anna Xavier Kalani AB dba Kalani Sunwear Brahegatan 28 114 37 Stockholm Sweden info@kalani.se Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 12, 2025 - 13:46 GMT

K & Care Organics - 711000 - 08/06/2025

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Shirly Gutshtat, CEO Recipient Title Keren Elisar, Founder & President K & Care Organics Simtat Hadayagim 2 St Mikhmoret 4029700 Israel info@kcare.co.il Issuing Office: Center for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 12, 2025 - 13:46 GMT

Fallien Cosmeceuticals Ltd. dba Fallene Ltd. - 711006 - 08/06/2025

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Dr. Harry Fallick Recipient Title Founder & CEO Fallien Cosmeceuticals Ltd. dba Fallene Ltd. 2541 General Armistead Ave Norristown, PA 19403 United States info@tizoskin.com Issuing …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 12, 2025 - 13:46 GMT

Supergoop! - 711018 - 08/06/2025

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Lisa Sequino Supergoop! 200 East Grayson Suite #110 San Antonio, TX 78215 United States hello@supergoop.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 12, 2025 - 13:46 GMT

Gussyup LLC dba Private Label Grooming - 709488 - 07/09/2025

Delivery Method: VIA UPS Reference #: 320-25-90 Product: Drugs Recipient: Recipient Name Mr. Neal Flowers Recipient Title President Gussyup LLC dba Private Label Grooming 7360 Eastgate Rd, Suite 135 Henderson, NV 89011-4091 United States Issuing Office: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 12, 2025 - 13:02 GMT

FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic Anemia

For Immediate Release: December 08, 2025 The U.S. Food and Drug Administration today announced it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). …

Distribution channels: Food & Beverage Industry

Published on August 12, 2025 - 12:09 GMT

Generic Drugs Program Fiscal Year 2025 Activities Report

As outlined in the GDUFA III Commitment Letter, these performance metrics must be reported each fiscal year. Original and PAS Review GDUFA FY Performance Review Time Goal Actions Completed Percent on Time Potential Range On-Time Imminent Action Imminent …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 11, 2025 - 20:31 GMT

In Response to a Broader FDA Investigation, ByHeart Initiates a Voluntary Recall of Two Batches of Infant Formula

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 August 10, 2025 - 19:19 GMT

Neuhaus Issues Allergy Alert on Undeclared Wheat in Belgian Chocolate Moments Smurf’s Popping Milk Chocolates with Cookies'

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 August 10, 2025 - 17:43 GMT

Tai Foong USA Issues Allergy Alert on Undeclared Shrimp in Fusia Asian Inspirations Veggie Spring Rolls

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 August 10, 2025 - 14:14 GMT

FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma

On October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 10, 2025 - 12:50 GMT

Replacing and Reducing Animal Testing at CDER

Safety Pharmacology General safety pharmacology testing Safety pharmacology endpoints may be incorporated into general toxicity studies in order to reduce animal use. This practice is routine for biologics. May include non-animal methods. May be based on …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 9, 2025 - 18:55 GMT

DermaRite Industries Issues Voluntary Nationwide Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to ...

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: Healthcare & Pharmaceuticals Industry

Published on August 9, 2025 - 12:54 GMT

Middlefield Original Cheese Co-Op Recalls Organic Gouda, Colored Cheddar, Mozzarella/Provolone, Pepper Jack, Swiss, Dilly Pickle ...

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 August 9, 2025 - 11:02 GMT

FDA’s Sixth Online Controlled Substances Summit - 09/11/2025

On This Page Date: September 11, 2025 Time: 12:30 p.m. - 3:30 p.m. ET FDA, in partnership with the Reagan-Udall Foundation, will host the sixth Online Controlled Substances Summit. Illegal online sales of controlled substances pose significant health risks …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 9, 2025 - 08:58 GMT

Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations ...

Docket Number: FDA-2019-D-2102 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance describes the Agency’s recommendations on the design and evaluation of comparative …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 8, 2025 - 23:58 GMT

FDA Commissioner Makary, USDA Secretary Rollins Celebrate Proposed Modernization of Orange Juice Regulations to Benefit American ...

For Immediate Release: August 08, 2025 U.S. Food and Drug Administration Commissioner Dr. Marty Makary, M.D., M.P.H., and U.S. Secretary of Agriculture Brooke L. Rollins this week announced plans to support American citrus growers and cut bureaucratic …

Distribution channels: Food & Beverage Industry