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....
CDER Office of Medical Policy regulatory counsel Christopher Diamant explains why the new Patient Medication Information form was developed and how.
Two Polsinelli attorneys say the Supreme Courts refusal to hear an appeal in a labeling case helps manufacturers argue for preemption.
Patient nonprofit group Haystack Project confirms that former FDA principal deputy commissioner Janet Woodcock is playing an advisory role in its drug...
