FDA researchers examine the use of confirmatory evidence with one adequate and well-controlled trial in non-oncologic drug rare disease marketing appl...
FDA selects former consultant Barclay Butler as its deputy commissioner for operations and chief operating officer.
Advantage Silver Dental Arrest asks FDA to rescind medical device approvals for silver diamine fluoride and silver fluoride agents and regulate them a...
Axsome says its solriamfetol met the primary and secondary endpoints in the Phase 3 FOCUS trial in attention deficit hyperactivity disorder.
CBER director Peter Marks says vaccine clinical trial designs should evaluate the investigational vaccines effect on disease transmission.
FDA grants Powerful Medical a breakthrough device designation for its PMcardio STEMI artificial intelligence electrocardiogram model for detecting ST-...
FDA approves an Alnylam Pharmaceuticals supplemental NDA for Amvuttra (vutrisiran), an RNAi therapeutic for treating transthyretin amyloidosis with ca...
FDA approves a Novartis NDA for Fabhalta (iptacopan) for treating adults with C3 glomerulopathy to reduce proteinuria.
