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.

Milestone Pharmaceuticals announced the FDA approval of prescription etripamil nasal spray for the treatment of acute symptomatic episodes of paroxysmal supraventricular tachycardia in adults. Etripamil (Cardamyst) is the first self-administered rapid-acting treatment option for paroxysmal supraventricular tachycardia (PSVT) to receive regulatory approval,

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

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.

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

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

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,

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.