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.
FDA approves an Abbott IDE for a clinical trial to evaluate its investigational coronary intravascular lithotripsy system and its use for treating sev...
The government completes a construction project for a new 11,000 square feet FDA annex building in San Juan District as the Trump Administration eyes ...
