FDA approves label change for Depo-Provera, adding brain tumor warning

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

Kenvue faces FDA petition to remove key Benadryl ingredient

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

FDA commissioner on growing public mistrust of government health advice

FDA Commissioner Martin Makary discusses vaccine policy, COVID-era decisions and the erosion of trust in government health ...
The American Journal of Managed Care

FDA to Accept Deidentified Real-World Evidence for Select Medical Device Applications

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 ...

FDA OKs libido-boosting pill for older women who have gone through menopause

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

AstraZeneca, Daiichi's breast cancer drug gets FDA nod as first-line treatment

The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's Enhertu in combination with Roche ...

FDA approves first at-home device for depression. What is it?

The FDA has approved Flow Neuroscience's at-home brain stimulation device to treat depression, offering an alternative to ...