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The Biotechnology Innovation Organization urges FDA to broaden application of its draft guidance on Monoclonal Antibodies: Streamlined Nonclinical Saf...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...
FDA cites Ipca Laboratories over multiple manufacturing and quality deficiencies following an inspection of the companys active pharmaceutical ingredi...
