More recently, the FDA posted two two letters: one backdated for September 9, regarding GSK’s HIV medication Apretude and one ...

FDA's new guidance clarifies promotional practices for biosimilars, ensuring accurate marketing and preventing misleading ...

" It sounds wholesome, right? Pure. Like something your grandmother might have used in her kitchen. The clean label movement has exploded in recent years, with half of industry professionals ...

The drugs have soared in popularity, with some men taking them for unapproved uses like anti-aging or increasing muscle mass.

Studies in the early 2000s claimed there were major risks associated with HRT. The Food and Drug Administration said Monday it will remove the "black box" warning from hormone replacement therapy (HRT ...

Theresa Gaffney is the lead Morning Rounds writer and reports on health care, new research, and public policy, with a particular interest in mental health, gender-affirming care, and LGBTQ+ patient ...

Republican senators on Wednesday urged the Food and Drug Administration (FDA) to tighten safety standards and reconsider partnerships tied to abortion pills, accusing the agency of expanding access ...

More and more, as momentum builds for the soon-to-be-blockbuster Winrevair, Merck’s $11.5 billion buyout of Acceleron in 2021 is looking like a savvy move. The FDA has signed off on a label update for ...

Sotatercept-csrk is approved for improving exercise capacity and reducing clinical worsening in PAH patients, following FDA label expansion. The ZENITH trial showed a 76% reduction in major morbidity ...