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

Published on April 22, 2025 - 14:23 GMT

Empower Clinic Services, LLC dba Empower Pharma - 700962 - 04/02/2025

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Arta Shaun Noorian Recipient Title Chief Executive Officer Empower Clinic Services, LLC dba Empower Pharma 5980 West Sam Houston Parkway North, Suite 300 Houston, TX 77041-5254 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 19, 2025 - 02:22 GMT

Amneal Pharmaceutical LLC Issues a Nationwide Recall of Ropivacaine Hydrochloride Injection, USP 500mg/100mL, Due to the ...

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 April 19, 2025 - 02:22 GMT

FDA Classifies Q’Apel Medical Inc.’s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as ...

Summary Company Announcement Date: April 18, 2025 FDA Publish Date: April 18, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Distal Tip Design outside scope of 510k clearance Company Name: Q’Apel Medical, Inc. Brand …

Distribution channels: Food & Beverage Industry

Published on April 18, 2025 - 17:38 GMT

Recall Reminder: Gerber Products Company Previously Recalled and Discontinued All Batches of Gerber® Soothe N Chew® Teething ...

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 April 17, 2025 - 20:10 GMT

FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees

For Immediate Release: April 17, 2025 In keeping with U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr.’s promise to carry out the Department’s work with “radical transparency” and mitigate perceived industry influence and …

Distribution channels: Food & Beverage Industry

Published on April 16, 2025 - 21:21 GMT

POSTPONED - Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity ...

After much consideration, we are postponing the Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act and will reschedule it to occur in the coming months. This meeting is important to all …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 16, 2025 - 15:30 GMT

Harvest NYC Inc Recalls Enoki Mushroom Due to 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 April 15, 2025 - 14:59 GMT

PMS4PMS, LLC - 700180 - 04/07/2025

Delivery Method: VIA UPS Reference #: 320-25-62 Product: Drugs Recipient: Recipient Name Ms. Lina M. Kennedy Recipient Title President and CEO PMS4PMS, LLC 4255 Research Pkwy Clarence, NY 14031-2032 United States Issuing Office: Center for Drug Evaluation …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 15, 2025 - 14:59 GMT

Nubratori, Inc. dba Nubratori Rx - 700513 - 01/22/2025

Delivery Method: Via Electronic Mail - Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Robert P. Nickell Nubratori, Inc. dba Nubratori Rx 381 Van Ness Avenue, Suite 1507 Torrance, CA 90501-7220 United States Issuing Office: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 15, 2025 - 14:59 GMT

Naturista Store LLC - 701480 - 03/26/2025

Delivery Method: Via Email Product: Drugs WARNING LETTER March 26, 2024 RE: 701480 Dear Andy Garcia: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://naturistastore …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 14, 2025 - 21:52 GMT

Lot Distribution Database (LDD)

Background This procedure is intended to assist manufacturers of vaccines and other biological products to electronically submit post marketing lot distribution data to FDA under 21 CFR 600.81. Most manufacturers have submitted biological product lot …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 14, 2025 - 14:48 GMT

Supplement Manufacturing Partner, Inc. Issues Recall on Dorado Nutrition Brand Spermidine Supplement 10mg Vegetable Capsules (...

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 April 12, 2025 - 17:04 GMT

FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma

On December 4, 2025, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company) for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 12, 2025 - 16:55 GMT

FDA Approves First CAR T-Cell Therapy for Marginal Zone Lymphoma In the US

For Immediate Release: December 04, 2025 The U.S. Food and Drug Administration today approved a new indication for Breyanzi (Lisocabtagene maraleucel) as the first Chimeric Antigen Receptor (CAR) T-cell therapy in the U.S. for treatment of adults with …

Distribution channels: Food & Beverage Industry, Healthcare & Pharmaceuticals Industry

Published on April 12, 2025 - 14:01 GMT

Drug Trials Snapshot: LYNOZYFIC

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 April 12, 2025 - 11:42 GMT

Public Meeting: FDA Rare Disease Day 2026 - 02/23/2026

On This Page Date: February 23, 2026 Time: 9:00 a.m. - 4:00 p.m. ET Image Summary FDA will host Rare Disease Day, a virtual public meeting, on Monday, February 23, 2026 in global observance of Rare Disease Week. The theme is: “Moving Forward. Looking Ahead …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 11, 2025 - 23:51 GMT

Duda Farm Fresh Foods, Inc. Emite Aviso Para 1.587 Cajas de Marketside 4in/1.6 oz Bundle Pack por Posible Riesgo Para la Salud ...

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 April 11, 2025 - 21:35 GMT

FDA Honored to Welcome HHS Secretary Robert F. Kennedy, Jr. to FDA Campus

For Immediate Release: April 11, 2025 The U.S. Food and Drug Administration today welcomed HHS Secretary Robert F. Kennedy, Jr. to its headquarters in Silver Spring, Maryland, a visit that included remarks to FDA employees, meetings with agency leadership, …

Distribution channels: Food & Beverage Industry

Published on April 11, 2025 - 21:04 GMT

May Flower International Inc., Issue Allergy Alert on Undeclared Wheat in “Beijing Soybean Paste”

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 April 11, 2025 - 20:14 GMT

JFE Franchising, Inc. Issues a Voluntary Recall Associated with a Nationwide Peach Recall 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