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

Published on July 9, 2025 - 13:29 GMT

Compounding Quality Center of Excellence | Annual Conference - 08/25/2025

Conference | Mixed Meeting Patient Needs for Quality, Safety, Integrity and Access On This Page Date: August 25 - 28, 2025 Day1: Mon, Aug 25 2:00 p.m. - 05:00 p.m. ET Day2: Wed, Aug 27 9:00 a.m. - 06:00 p.m. ET Day3: Thu, Aug 28 9:00 a.m. - 04:30 p.m. ET …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 9, 2025 - 01:40 GMT

FDA Grand Rounds – Forensic Proteomics Applied to FDA-Regulated Products - 07/31/2025

On This Page Date: July 31, 2025 Time: 12:00 p.m. - 1:00 p.m. ET Speaker David M. Skelton, PhD Chemist National Forensic Chemistry Center Office of Specialty Laboratories and Enforcement Support Office of the Chief Scientist Office of the Commissioner U.S …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 9, 2025 - 01:27 GMT

Versace Real Honey for Men may be harmful due to hidden drug ingredients

[7-8-2025] The Food and Drug Administration is advising consumers not to purchase or use Versace Real Honey for Men, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. FDA laboratory analysis …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 9, 2025 - 01:27 GMT

Black Panther Miracle Honey for Men may be harmful due to hidden drug ingredients

[7-8-2025] The Food and Drug Administration is advising consumers not to purchase or use Black Panther Miracle Honey for Men, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. FDA laboratory analysis …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 9, 2025 - 01:27 GMT

Secret Miracle Honey Extra Strength may be harmful due to hidden drug ingredients

[7-8-2025] The Food and Drug Administration is advising consumers not to purchase or use Secret Miracle Honey Extra Strength, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. FDA laboratory analysis …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 9, 2025 - 01:27 GMT

Black Horse Miracle Honey for Men may be harmful due to hidden drug ingredients

[7-8-2025] The Food and Drug Administration is advising consumers not to purchase or use Black Horse Miracle Honey for Men, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. FDA laboratory analysis …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 8, 2025 - 22:21 GMT

Mondelēz Global LLC Conducts U.S. Voluntary Recall of Four Carton Sizes of RITZ Peanut Butter Cracker Sandwiches Due to Labeling ...

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 July 8, 2025 - 16:39 GMT

Dynamic Blending Specialists, Inc. - 701278 - 06/18/2025

Delivery Method: VIA Electronic Mail Reference #: 320-25-83 Product: Drugs Recipient: Recipient Name Mr. Gavin Victor Collier Dynamic Blending Specialists, Inc. 523 East 1750 N., Suite 100 Vineyard, UT 84059-8109 United States Issuing Office: Center for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 8, 2025 - 16:38 GMT

Xtreme Tools International, Inc. - 706053 - 06/25/2025

Delivery Method: VIA Electronic Mail Reference #: 320-25-85 Product: Drugs Recipient: Recipient Name Mr. Ali Mithavayani Recipient Title Owner/Chief Executive Officer (CEO) Xtreme Tools International, Inc. 15400 NW 34th Avenue Opa Locka, FL 33054-2461 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 8, 2025 - 16:38 GMT

Libby Laboratories, Inc. - 708259 - 06/27/2025

Delivery Method: VIA Electronic Mail Reference #: 320-25-87 Product: Drugs Recipient: Recipient Name Ms. Susan Carol Libby President Recipient Title President Libby Laboratories, Inc. 1700 Sixth Street Berkeley, CA 94710 United States Issuing Office: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 8, 2025 - 15:51 GMT

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live): FDA Safety Communication

FDA Removes Recommended Pause in Use and Approves Required Updated Labeling AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel Clinics ISSUE: On May 9, 2025, FDA issued a safety …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 8, 2025 - 09:39 GMT

FDA’s Actions to Address Unapproved Thyroid Medications

Medications for treatment of hypothyroidism Hypothyroidism is a condition of decreased thyroid hormone production from the thyroid gland, which affects about 2% of the adult population in the United States. Millions of Americans take thyroid hormone …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 8, 2025 - 09:32 GMT

FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing

For Immediate Release: August 07, 2025 The U.S. Food and Drug Administration today announced FDA PreCheck, a new program to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of …

Distribution channels: Food & Beverage Industry

Published on July 7, 2025 - 20:31 GMT

Endothelin Receptor Antagonist REMS Information

Based on a new analysis of human pregnancy data compiled from the use of endothelin receptor antagonist (ERA) medicines for two decades, FDA has determined that risk evaluation and mitigation strategy (REMS) requirements related to embryofetal toxicity ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 7, 2025 - 20:31 GMT

Drug Trials Snapshot: ROMVIMZA

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 July 7, 2025 - 20:31 GMT

FDA Public Meeting: BsUFA III Regulatory Science Program Interim Public Meeting - 09/18/2025

On This Page Date: September 18, 2025 Time: 9:00 a.m. - 3:00 p.m. ET Under the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 to 2027 (BsUFA III), FDA committed to piloting a regulatory science program that focuses …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 30, 2025 - 22:44 GMT

FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD

Through Pediatric Research Equity Act (PREA) postmarketing requirements (PMR), FDA required drug sponsors to evaluate pharmacokinetics (PK), efficacy, and safety of extended-release stimulants in children 4 to 5 years of age. Although the Agency determined …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 30, 2025 - 13:00 GMT

January - March 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting ...

ELEVIDYS (delandistrogene moxeparvovec-rokl) Hepatotoxicity-associated fatalities in non-ambulatory patients with Duchenne muscular dystrophy FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on June 24, 2025: FDA …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 28, 2025 - 22:13 GMT

Nirwana Foods Issues Allergy Alert on Undeclared Sulfites on Golden Raisin 28Oz Pouch Label

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 June 28, 2025 - 01:35 GMT

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell ...

FDA News Release Agency determines the safety and effectiveness of these immunotherapies can be assured without a REMS For Immediate Release: June 27, 2025 The U.S. Food and Drug Administration announced today that it has eliminated the Risk Evaluation and …

Distribution channels: Food & Beverage Industry