FDA clears a Median Technologies 510(k) for eyonis LCS, the first artificial intelligencebased device cleared for both detection and diagnosis in lung...
FDA drug regulators and pharmaceutical industry representatives reach a partial agreement on drug development tools, including biomarker qualification...
Faced with increasing FDA scrutiny and litigation threats from Novo Nordisk, Hims & Hers abruptly shelves its GLP 1 weight loss pill offering.
The Biotechnology Innovation Organization urges FDA to broaden application of its draft guidance on Monoclonal Antibodies: Streamlined Nonclinical Saf...
FDA approves a Kite Oncology labeling update for CAR-T therapy Yescarta (axicabtagene ciloleucel), removing a previous limitation on its use in patien...
FDA pledges to move quickly against companies that mass-market illegal copycat drugs by portraying them as equivalent to agency-approved medicines, co...
FDA grants Sonorous Neurovascular a breakthrough device designation for its BosSTENT, a cerebral venous stent designed to treat debilitating pulsatile...
A new poll finds public confidence in FDA and Centers for Disease Control and Prevention remains low following recent changes to the federally recomme...
