FDA approves Takedas Entyvio (vedolizumab) subcutaneous administration for maintenance therapy in adults with moderately to severely active Crohns dis...
The Advanced Medical Technology Association says FDAs draft guidance on diversity plans for clinical trials needs to address what sponsors should do i...
AbbVie reports positive top-line results from SELECT-GCA, a Phase 3, placebo-controlled study that showed the companys arthritis drug Rinvoq (upadacit...
GlaxoSmithKline says a follow-up trial of its Shingrix found 80% effectiveness in adults over age 50 up to 11 years after vaccination.
Philips Respironics recalls its Trilogy Evo ventilator and all software versions, except 1.05.06.00, due to the devices potential for sudden loss of v...
FDA approves Lumicells Lumisight to assist in the detection of cancerous tissue in breast cancer patients undergoing a lumpectomy.
Federal Register notice: FDA issues a priority review voucher to Orchard Therapeutics for its rare pediatric disease drug approval for Lenmeldy (atida...
Federal Register notice: FDA sends to OMB an information collection extension entitled Expedited Programs for Serious Conditions Drugs and Biologics....
