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

Published on September 11, 2025 - 15:24 GMT

CDER Statistical Studies Innovate Measures of Adhesion to Assess Generic Products

Drugs and the technologies used to deliver them evolve rapidly, and methods to evaluate them must be continually adapted to ensure the safety and efficacy of new medicines. An excellent illustration of this process of adaptation is recent work by Center …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 11, 2025 - 03:28 GMT

Chetak LLC Group Expands Voluntary Product Recall to Include Additional Frozen Vegetable and Fruit Products Due to Possible Health ...

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 September 11, 2025 - 03:28 GMT

One Frozen, LLC Voluntarily Recalls Good & Gather™ Southwest Style Burrito Bowl Blend, Frozen, 12oz Bags Due to Undeclared Shrimp ...

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 September 11, 2025 - 01:19 GMT

Gina Marie Bakery of Waterbury Issues Recall of Cookies Due to Undeclared Almonds, Sesame and Food Dyes

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 September 11, 2025 - 00:51 GMT

XYNTHA

STN: BL 125264 Proper Name: Antihemophilic Factor (Recombinant), Plasma/Albumin Free Tradename: XYNTHA Manufacturer: Wyeth Pharmaceuticals, LLC Indication: XYNTHA is a recombinant antihemophilic factor indicated in adults and children with hemophilia A …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 10, 2025 - 20:57 GMT

FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb Misuse

For Immediate Release: September 10, 2025 Despite recent declines, opioids remain commonly prescribed to about 1 in 5 U.S. adults who live with chronic pain as effective alternatives are limited. As part of its broader strategy to address the opioid crisis …

Distribution channels: Food & Beverage Industry

Published on September 10, 2025 - 20:57 GMT

Development of Non-Opioid Analgesics for Chronic Pain

Docket Number: FDA-2025-D-0610 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 “Development of Non-Opioid …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 10, 2025 - 20:57 GMT

FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable ...

On September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 10, 2025 - 20:45 GMT

HHS, CBP Seize $86.5 Million Worth of Illegal E-Cigarettes in Largest-Ever Operation

For Immediate Release: September 10, 2025 The U.S. Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), and U.S. Customs and Border Protection (CBP) today announced the seizure of 4.7 million units of …

Distribution channels: Food & Beverage Industry

Published on September 10, 2025 - 18:11 GMT

Foodynamics Recalls Raw Dog Barkery, BellePepper Cats, and Kanu Pets Brand Freeze-Dried Pet Treats Because Of Possible Salmonella ...

Summary Company Announcement Date: October 09, 2025 FDA Publish Date: October 09, 2025 Product Type: Animal & Veterinary Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Salmonella …

Distribution channels: Food & Beverage Industry

Published on September 10, 2025 - 14:54 GMT

Sprouts Farmers Market is Recalling Smoked Mozzarella Pasta Salad 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

Published on September 9, 2025 - 23:20 GMT

FDA Launches Crackdown on Deceptive Drug Advertising

For Immediate Release: September 09, 2025 The U.S. Department of Health and Human Services and the Food and Drug Administration today announced sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements. Today, the FDA is …

Distribution channels: Food & Beverage Industry

Published on September 9, 2025 - 20:55 GMT

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 9, 2025 - 13:49 GMT

Hikal Limited - 709370 - 08/20/2025

Delivery Method: Via Email Reference #: 320-25-102 Product: Drugs Recipient: Recipient Name Dr. K Suresh Babu Recipient Title Head – Corporate Quality and Regulatory Affairs Hikal Limited 72 - 82 / A Kiadb Industrial Area Jigani 560105 Karnataka India …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 9, 2025 - 13:49 GMT

Shirish M. Gadgeel, M.D. - 716181 - 09/04/2025

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-09-01 Product: Drugs Recipient: Shirish M. Gadgeel, M.D. 2799 West Grand Boulevard Detroit, MI 48202-2608 United States Issuing Office: Center for Drug Evaluation and Research …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 8, 2025 - 15:45 GMT

Lee K of NY Issue Allergy Alert on Undeclared Allergen (Milk and Shrimp) in “Stewed Aged Kimchi w/Mackerel”

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 30, 2025 - 00:43 GMT

Updated Release: Southwind Foods, LLC Recalls Frozen Shrimp 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

Published on August 29, 2025 - 20:22 GMT

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting ...

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 29, 2025 - 20:22 GMT

April - June 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System ...

Adcetris (brentuximab vedotin) Guillain-Barre syndrome FDA determined that no action is necessary at the time based on available information. Arzerra (ofatumumab) Gazyva (obinutuzumab) Riabni (rituximab-arrx) Rituxan (rituximab) Rituxan Hycela (rituximab …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 29, 2025 - 20:22 GMT

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting ...

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information…

Distribution channels: Healthcare & Pharmaceuticals Industry