US FDA

An informative webinar on the FDA guidance Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

The FDA must maintain a delicate balance: being a model of openness regarding the scientific basis of its decisions, while safeguarding the proprietary secrets of the industries it regulates as well as personal data.

Cottonwood Heights, Utah (February 26, 2026) Go Raw LLC is expanding its February 17, 2026, voluntary recall of a freeze-dried product to add two lots of select Quest Cat Food Chicken Recipe frozen products due to potentially low levels of thiamine (Vitamin B1).
The two lots of Quest Cat Food Chicke

Fresenius Kabi is correcting Ivenix LVP software due to anomalies that could cause serious patient harm or death

Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint

This listing includes accelerated approvals (AAs) for non-malignant hematological, neurological, and other disorder indications with postmarketing trials that have been subsequently withdrawn, and are therefore, no longer FDA-approved.

02/252026-McKinney, Texas, Lockout Supplements is voluntarily recalling all lots of Boner Bears Chocolate Syrup. This product has been found to contain sildenafil not listed on the product label.

Impella Generation 1 Purge Cassettes have an increased risk of purge leaks. Purge leaks can lead to low pump pressure and pump stops

February 24, 2026-Elite Treats, LLC. of Boca Raton, FL, is recalling a single lot of “Elite Treats Chicken Chips for Dogs” 6-ounce bags because it may be contaminated with Salmonella. The product is packaged in a 6-ounce black and gold bag marked on the back side with lot number 24045 and an expirat

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 not advisable. This is the first approval for

CGMP/Finished Pharmaceuticals/Adulterated

CGMP/Finished Pharmaceuticals/Adulterated