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

Published on March 3, 2026 - 13:55 GMT

New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers

Docket Number: FDA-2024-D-4388 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “New Clinical …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 3, 2026 - 13:55 GMT

M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data ...

Docket Number: FDA-2024-D-2754 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 final guidance for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 3, 2026 - 12:41 GMT

Azurity Pharmaceuticals, Inc. - 656489 - 03/24/2026

Reference #: FEI 3003395329 Product: Drugs Recipient: Recipient Name Mr. Ronald Scarboro Azurity Pharmaceuticals, Inc. 900 Ridgefield Drive Raleigh, NC 27609 United States rscarboro@azurity.com Issuing Office: Center for Drug Evaluation and Research (CDER …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 28, 2026 - 04:35 GMT

Savannah Bee Company Recalls Honey BBQ Sauce-Mustard Due to Undeclared Wheat 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 …

Distribution channels: Food & Beverage Industry

Published on February 27, 2026 - 22:04 GMT

USA LESS Co. is Recalling Rhino Choco VIP 10X Due to Undeclared Tadalafil

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 February 27, 2026 - 18:34 GMT

Drug Trials Snapshot: HYRNUO

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 February 27, 2026 - 11:27 GMT

Drug Trials Snapshots: EXDENSUR

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 February 27, 2026 - 02:46 GMT

Why Protecting Confidential Information is Key to the FDA’s "Gold Standard"

Image By: Barclay Butler, Ph.D., Deputy Commissioner for Operations and Chief Operating Officer When Americans look to the U.S. Food and Drug Administration, they are expecting to see the "Gold Standard" of regulatory review—the rigorous …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 27, 2026 - 02:00 GMT

ULTRA ADVANC3 and ULTRA ADVANC3 GOLD may be harmful due to hidden drug ingredients

[2-26-2026] The Food and Drug Administration is advising consumers not to purchase or use ULTRA ADVANC3 sold on www.amazon.com or ULTRA ADVANC3 GOLD sold on www.naturistarex.com. These products are promoted and sold for joint pain on various other websites …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 26, 2026 - 22:19 GMT

Drug Trials Snapshots: KOMZIFTI

What are the possible side effects (results of trials used to assess safety)? Table 4. Safety Results, Safety Population Adverse Reaction KOMZIFTI, N=112 All Grades† % Grade 3 or 4 % Infections and infestations Infection without identified pathogena …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 26, 2026 - 20:35 GMT

GO Raw LLC. Expands Voluntary Recall of Quest Diet Cat Food Products Due to Low Thiamine Levels and Enacts Stop Sale of All Quest ...

Summary Company Announcement Date: February 26, 2026 FDA Publish Date: February 26, 2026 Product Type: Animal & Veterinary Food & Beverages Pet Food Reason for Announcement: Recall Reason Description May contain low levels of thiamine (Vitamin B1) …

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Published on February 26, 2026 - 18:34 GMT

FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer

On February 26, 2026, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 26, 2026 - 18:34 GMT

Online Advisory Letters

2025/12/04 Bodynplant bodynplant.com Vaginal-Uterine Cancer Bundle, Stomach Cancer Bundle, Pancreas Cancer Bundle, Liver Cancer Bundle, Kidney Cancer Bundle, HIV-AIDS Bundle, Diabetes Bundle, Prostate Cancer Bundle, Colon Cancer Bundle, Cervical Cancer …

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Published on February 26, 2026 - 18:11 GMT

FDA Grants Second Approval under the National Priority Voucher Pilot Program

For Immediate Release: February 26, 2026 The U.S. Food and Drug Administration today issued an approval for the lung cancer drug Hernexeos (zongertinib) as a part of the new Commissioner's National Priority Voucher (CNPV) pilot program. The application …

Distribution channels: Food & Beverage Industry

Published on February 26, 2026 - 04:53 GMT

Lockout Supplements Issues Voluntary Nationwide Recall of Boner Bears Chocolate Syrup Due to Undeclared Sildenafil

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 February 26, 2026 - 04:53 GMT

Saputo USA Recalls Great Value Cottage Cheese 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 February 25, 2026 - 01:46 GMT

Elite Treats LLC Recalls Single Lot of Chicken Chips Due to Salmonella Contamination

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 February 24, 2026 - 23:14 GMT

Dynamic Stem Cell Therapy - 712579 - 02/11/2026

Delivery Method: VIA UPS and Electronic Mail Reference #: CBER 25-712579 Product: Biologics Recipient: Recipient Name Dale Carrison, D.O., FACEP, FACOEP Recipient Title Medical Director Dynamic Stem Cell Therapy 2551 N. Green Valley Parkway Building C, …

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Published on February 24, 2026 - 22:07 GMT

FDA approves drug for adult and pediatric patients aged 6 and older with allergic fungal rhinosinusitis

The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) with a history of sino-nasal surgery or for whom surgery is …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 24, 2026 - 18:25 GMT

FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation

On February 24, 2026, the Food and Drug Administration granted traditional approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult …

Distribution channels: Healthcare & Pharmaceuticals Industry