Children in Mass. cannot have sunscreen applied by a teacher or camp staff member without prior permission from a doctor, with a parent signing off.

Bayer said the Food and Drug Administration extended the review period for its new drug application of elinzanetant, a treatment for moderate to severe vasomotor symptoms, also known as hot flashes, ...

The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

Nelipak® Corporation ('Nelipak®”), a leading global provider of healthcare packaging solutions for medical device, diagnostic ...

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

A potential target for experimental drugs that block PRMT5—a naturally occurring enzyme some tumors rely more on for survival ...