The U.S. Food and Drug Administration has approved Omisirge (omidubicel-onlv) as the first hematopoietic stem cell transplant ...

The FDA has approved berotralstat oral pellets for prophylactic use in patients aged 2 to than 12 years with hereditary ...

The U.S. Food and Drug Administration (FDA) recently announced a recall of Boar’s Head Grated Pecorino Romano Cheese and FS Grated Romano Cheese after discovering that they may be contaminated with ...

Hormone therapies for menopause will no longer carry a black box warning about serious risks such as breast cancer, heart attack and stroke, the Food and Drug Administration announced Monday. In the ...

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 ...

(CNN) — Kenvue, the American company that makes Tylenol, says the US Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research about a possible ...