Greenleaf Health adds former FDAers Julia Barrett, Chris Leptak, and Grace McNally to its regulatory consulting staff.
FDA says it will not meet the already-extended PDUFA action dates for Pfizer submissions for abrocitinib and Xeljanz.
FDA says it is soliciting applications for new Patient Engagement Collaborative members.
FDA grants full approval to the combination of Mercks Keytruda and Eisais Lenvima for treating certain patients with advanced endometrial carcinoma.
An Annenberg Public Policy Center poll shows that the degree of confidence in FDA respondents have varies with their primary source of media.
CDRH director Jeff Shuren says two important lessons learned during the Covid-19 emergency that CDRH envisions continuing long after the pandemic ends...
An FDA Notice of Violation says The Regen Centers is marketing unapproved cellular products and exosomes.
The House Energy and Commerce Committee asks FDA acting commissioner Janet Woodcock what the agency intends to do about delayed drug manufacturing fac...