Pfizer faces a lawsuit in which women allege the drugmaker failed to warn them about the risks of meningioma associated with the birth control shot.

The FDA announced a voluntary recall of non-dairy frozen dessert pints sold at stores nationwide over the potential presence of small stones.

Kenvue Inc. is dealing with another challenge to a top-selling product as it attempts to close its $40 billion acquisition by Kimberly-Clark Corp.

The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that restricted the use of RWE in product applications, potentially accelerating treatment approvals.

FDA Commissioner Martin Makary discusses vaccine policy, COVID-era decisions and the erosion of trust in government health guidance.

Supplements aren’t reviewed for safety and effectiveness, but disclaimers about health benefits are required on products.

The U.S. health regulator has approved GSK's add-on drug to treat severe asthma, the drugmaker said on Tuesday, paving the way for a less frequently dosed treatment option for patients to enter the market.

U.S. health officials have expanded approval of a drug that boosts libido in women who report stress due to a low sex drive.

Black box warnings are the FDA’s bluntest regulatory instrument short of a recall. Yet despite what headlines, pundits, and influencers often suggest, they are neither a moral verdict nor the final word on a drug’s safety.

The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's Enhertu in combination with Roche's drug, Perjeta, for the first-line treatment of patients with a type of breast cancer,