FDA

In his resignation letter, Dr. Aaron Kesselheim calls it "probably the worst drug approval decision in recent U.S. history." An FDA official says the agency found the benefits outweighed the risks.

When a new drug is up for FDA approval, trials may be held not only in the U.S. but other countries too. A study looks at global availability after approval. Big Pharma disagrees with the findings.

Johnson & Johnson says the FDA approved extending the three-month shelf life to 4 1/2 months. The extension comes as the number of U.S. vaccinations continues to slip.

Aduhelm was recently approved by the FDA and quickly sparked controversy over its price and questionable benefits.

This is the first new drug approved for Alzheimer's disease since 2003. It's the first to show significant progress against the sticky brain plaques that are the hallmark of Alzheimer's disease.

In company-funded studies, participants taking the Novo Nordisk drug Wegovy had average weight loss of about 34 pounds. In a comparison group getting dummy shots, the average loss was under 6 pounds.

The agency is to decide by Monday whether to greenlight Biogen’s drug aducanumab, despite a near-unanimous rejection of the product by an FDA advisory committee of outside experts in November.

Gov. Ron DeSantis said importing prescription drugs through a Canadian wholesaler could save Floridians between $80 million and $150 million a year.

Company officials intend to submit its teen data to the Food and Drug Administration and other global regulators early next month.

Efforts to get as many adolescents vaccinated as possible before school restarts this fall are already underway.