FDA says Office of New Drugs director Peter Stein will decide an Akebia Therapeutics formal dispute resolution request over the complete response lett...
FDA extends to 5/22 the PDUFA priority review action date for Astellas fezolinetant to treat some menopausal vasomotor symptoms.
Communications experts tell the Associated Press FDA may have a hard time combating misinformation due to several factors, including its reputation an...
Federal Register notice: FDA sends to OMB an information collection extension entitled Biologics License Applications (BLAs) Procedures and Requiremen...
Federal Register notice: FDA revises an information collection entitled Premarket Notification 21 CFR Part 807, Subpart E.
FDA publishes two 510(k) guidances on ultrasound and related types of devices.
Intarcia Therapeutics accepts an FDA proposal to allow an advisory committee to review and address a 2021 CDER decision not to approve the companys Ty...
Merck says a study of its Covid-19 drug Lagevrio (molnupiravir) did not meet the primary endpoint a statistically significant risk reduction in those...
