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

Published on April 8, 2025 - 17:24 GMT

FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer

On April 8, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for adult and pediatric patients 12 years of age and older with unresectable or metastatic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 8, 2025 - 15:42 GMT

FDA Names Top HHS Lawyer as Chief Counsel

For Immediate Release: August 04, 2025 WASHINGTON — The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced that Sean Keveney has been appointed Chief Counsel at the FDA. Keveney most recently …

Distribution channels: Food & Beverage Industry

Published on April 8, 2025 - 14:13 GMT

www.thesafepills.org - 702942 - 03/27/2025

Recipient: www.thesafepills.org Singapore Issuing Office: Center for Drug Evaluation and Research (CDER) United States TO: www.thesafepills.org FROM: The United States Food and Drug Administration RE: Notice of Unlawful Sale of Unapproved and Misbranded …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 8, 2025 - 10:26 GMT

Native Remedies dba Silver Star Brands - 612268 - 02/18/2021

Delivery Method: Via Overnight Delivery Product: Drugs Food & Beverages Recipient: Recipient Name Bruce Valk Native Remedies dba Silver Star Brands 250 City Center Oshkosh, WI 54906 United States Issuing Office: Center for Food Safety and Applied …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 8, 2025 - 08:30 GMT

FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use: Drug Safety ...

Class-Wide Action Will Further Emphasize and Characterize Risks of Long-Term Use to Help Patients, Health Care Professionals Make Informed Treatment Decisions AUDIENCE: Patient, Health Care Professional, Pain Management ISSUE: In May 2025, the FDA convened …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 7, 2025 - 21:34 GMT

Bausch + Lomb Announces Voluntary Recall of enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses in ...

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 April 7, 2025 - 19:18 GMT

Max Mobility / Permobil Expands Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User

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 April 6, 2025 - 18:00 GMT

Firehook of Virginia Issues Allergy Alert on Undeclared Sesame in Classic Sea Salt Crackers

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 6, 2025 - 17:59 GMT

Tgd Cuts, LLC Initiated Voluntary Recall of Cucumber from Bedner Growers Inc., Which Had the Potential to Be Contaminated with ...

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 6, 2025 - 14:57 GMT

Amneal Pharmaceutical LLC Issues a Nationwide Recall of Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg Only, 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: Food & Beverage Industry, Healthcare & Pharmaceuticals Industry

Published on April 6, 2025 - 14:42 GMT

Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction

Docket Number: FDA-2007-D-0435 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Obesity and Overweight: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 6, 2025 - 14:42 GMT

Considerations for Including Tissue Biopsies in Clinical Trials

Docket Number: FDA-2024-D-2402 Issued by: Guidance Issuing Office Oncology Center of Excellence This guidance provides recommendations to industry, investigators, institutions, and institutional review boards (IRBs) regarding considerations for tissue …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 6, 2025 - 09:16 GMT

Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers

Submit Comments by 08/04/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 6, 2025 - 07:30 GMT

Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage ...

Docket Number: FDA-2025-D-1358 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled “Recommendations for Complying …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 6, 2025 - 07:24 GMT

Camerican International, Inc. Issues Allergy Alert on Undeclared Milk in Aldi Brand Casa Mamita Churro Bites Filled with Chocolate ...

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 March 31, 2025 - 19:52 GMT

October - December 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting ...

Alecensa (alectinib) capsules Alunbrig (brigatinib) tablets Lorbrena (lorlatinib) tablets Zykadia (ceritinib) capsules; tablets Optic neuropathy FDA is evaluating the need for regulatory action. Antidepressants Selective serotonin reuptake inhibitors ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 28, 2025 - 20:52 GMT

FDA approves durvalumab for muscle invasive bladder cancer

On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 28, 2025 - 19:52 GMT

FDA Roundup: March 28, 2025

For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA’s Learning and Education to ADvance and Empower Rare Disease Drug Developers …

Distribution channels: Food & Beverage Industry

Published on March 28, 2025 - 19:52 GMT

FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors

FDA News Release Medication Can be Given Up to Once Every 2 Months For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 28, 2025 - 17:12 GMT

FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication

On March 28, 2025, the Food and Drug Administration expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) to include adults with prostate-specific membrane antigen (PSMA)-positive metastatic …

Distribution channels: Healthcare & Pharmaceuticals Industry