The FDA has granted orphan drug designation (ODD) to a locally delivered formulation of irinotecan (ChemoSeed) for the ...

This three-part series reviews how the Food and Drug Administration’s (FDA) January 2026 guidance, “General Wellness: Policy for Low Risk ...

Officials with the FDA have approved a label expansion for fluralaner for extended-release injectable suspension (Bravecto ...

Merck (MRK) stock is in focus as the FDA approves a label expansion for the company's once-yearly parasiticide treatment. Bravecto Quantum. Read more here.

The U.S. Food and Drug Administration approved GSK's drug for severe itching caused by a type ​of liver disease, the company said on Thursday.

NCCN now recognizes BCG-unresponsive papillary-only NMIBC as eligible for nogapendekin plus BCG, broadening access beyond the ...

The agency’s lengthy “Human Foods Program 2026 Priority Deliverables” targets food dyes and other ingredients, the GRAS ...

Stoke Therapeutics is developing a drug designed to reduce seizures and restore some of their lost developmental function.

Protagonist Therapeutics will now sit back and collect cash from the J&J partnership, including an immediate $50 million payment.

After delaying its review, the FDA has rejected Aldeyra Therapeutics’ experimental dry eye disease treatment for the third time. | After delaying its review, the FDA has rejected Aldeyra Therapeutics’ ...

Although FDA Commissioner Marty Makary promised “an exciting treatment” for autism, what the agency delivered was a label ...

The Food and Drug Administration has linked cheddar cheese made from raw (unpasteurized) milk to a multistate outbreak of ...