The FDA on Tuesday approved etuvetidigene autotemcel (Waskyra) as the first cell-based gene therapy for patients 6 months and ...

The U.S. Food and Drug Administration has approved an expanded indication for Eli Lilly's Jaypirca (pirtobrutinib), the first and only noncovalent Bruton tyrosine kinase (BTK) inhibitor for adults ...

Pharmacokinetic and safety studies were analyzed to demonstrate the safety and efficacy of TRN-257, as well as previous research on oxybate products.

Following the expanded approval, the accelerated approval for the later-line CLL/SLL was converted to a traditional approval.

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 ...

(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 ...

Tylenol maker Kenvue is calling on the Food and Drug Administration (FDA) to back off a proposed safety label change to acetaminophen after the Trump administration linked its use during pregnancy to ...

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