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

Published on December 15, 2025 - 19:17 GMT

Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs

Docket Number: FDA-2019-D-1264 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance recommends approaches that sponsors of clinical trials intended to support a new drug …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 15, 2025 - 19:17 GMT

Zoliflodacin - Oral Products

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Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 15, 2025 - 19:17 GMT

FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer

On December 15, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 15, 2025 - 18:09 GMT

FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews

For Immediate Release: December 15, 2025 The U.S. Food and Drug Administration (FDA) today removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews. In new guidance for certain types of medical device …

Distribution channels: Food & Beverage Industry

Published on December 15, 2025 - 16:36 GMT

FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results

For Immediate Release: December 15, 2025 The U.S. Food and Drug Administration today awarded a national priority voucher to teclistamab in combination with daratumumab for relapsed/refractory multiple myeloma. This brings the total number of products …

Distribution channels: Food & Beverage Industry

Published on December 15, 2025 - 14:42 GMT

Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices

Docket Number: FDA-2021-D-0368 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Oncology Center of Excellence The guidance is intended to help …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 15, 2025 - 14:42 GMT

Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies

Docket Number: FDA-2020-D-2099 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The guidance provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 12, 2025 - 21:25 GMT

White Castle Frozen Food Division Recalls Frozen 4-Count Cartons of Original Sliders Due to Undeclared Milk and Soy

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 …

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Published on December 12, 2025 - 21:25 GMT

South Asian Food Inc. Issues Allergy Alert on Undeclared Peanuts in "Bengal King Jhal Chanachur "

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 …

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Published on December 12, 2025 - 21:25 GMT

Town Food Service Equipment Co., Inc. Recalls Aluminum Saucepans Because of Possible Health Risk

Summary Company Announcement Date: December 12, 2025 FDA Publish Date: December 12, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Aluminum saucepans recalled because they have the potential to be contaminated …

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Published on December 12, 2025 - 19:23 GMT

FDA Approves Two Oral Therapies to Treat Gonorrhea

FDA News Release Approvals Are for Uncomplicated Urogenital Gonorrhea For Immediate Release: December 12, 2025 The U.S. Food and Drug Administration recently approved two new oral medicines to treat a common sexually transmitted infection called gonorrhea. …

Distribution channels: Food & Beverage Industry

Published on December 12, 2025 - 19:08 GMT

FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer

On December 12, 2025, the Food and Drug Administration approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 11, 2025 - 05:00 GMT

Ukrop’s Homestyle Foods Announces Recall Due to Undeclared Allergen

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 December 10, 2025 - 23:24 GMT

The James Skinner LLC Issues Voluntary Recall of Publix Maple Walnut Coffee Cake Due to Incorrect 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 December 5, 2025 - 22:18 GMT

Olympus Announces Voluntary Corrective Action for the Single-Use Ligating Device

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 November 28, 2025 - 17:45 GMT

QE3 Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs

Docket Number: FDA-2025-D-4678 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 …

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Published on November 28, 2025 - 14:36 GMT

Current Good Manufacturing Practice for Medical Gases

Docket Number: FDA-2003-D-0431 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Veterinary Medicine Office of Inspections and Investigations Office of the Commissioner, Office of Clinical Policy and Programs, Office of …

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Published on November 27, 2025 - 03:46 GMT

ITVISMA

STN: BL 125856/0 Proper Name: onasemnogene abeparvovec-brve Tradename: ITVISMA Manufacturer: Novartis Gene Therapies, Inc. Indication: For the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 27, 2025 - 00:28 GMT

Silvestri Sweets Issues Voluntary Allergy Alert on Undeclared Pecan and Wheat in Cookie Butter Holiday Bark and Pecan, Cranberry & ...

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 November 26, 2025 - 19:18 GMT

The Ambriola Company Issues Recall of Cheese Products Because of Listeria 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