FDA rejects Otsuka Pharmaceutical and H. Lundbecks sNDA to expand the use of Rexulti (brexpiprazole) for treating post-traumatic stress disorder in ad...
FDA takes two actions against autism by ordering a label change against acetaminophen (Tylenol) use in pregnancy approving leucovorin calcium tablets ...
Rep. Frank Pallone Jr. (D-NJ) sharply criticizes Health and Human Services Secretary Robert F. Kennedy Jr., accusing him of undermining vaccine access...
FDA approves Medtronics Altaviva implantable tibial neuromodulation device for treating urge urinary incontinence.
FDA schedules a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the strain selection for influenza...
FDA approves Mercks pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for subcutaneous injection for adult and pediatric solid tumor indic...
FDA escalates medical device oversight this year, issuing more Warning Letters and relying on artificial intelligence to zero-in on compliance gaps, a...
FDA publishes a final rule rolling back a 2024 regulation that expanded the agencys authority over laboratory-developed tests.
