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 ...
FDA passes on holding an advisory committee meeting to review a Tonix Pharmaceuticals NDA for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for ...
