Novartis23h
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G) Fabhalta is the only oral alternative complement pathway ...
Policy & Medicine19d
HHS OIG Reviews FDA’s Accelerated Approval of Aducanumab
Earlier this year, the United States Department of Health and Human Services Office of the Inspector General (HHS OIG) ...
Business Wire25d
Mirum’s CTEXLI™ (chenodiol) Tablets Receives FDA Approval for Treatment of Cerebrotendinous Xanthomatosis (CTX)
CTEXLI is the first and only medication approved for the treatment of CTX in adults Approval based on Phase 3 RESTORE study results CTEXLI granted U.S. FDA Orphan Drug exclusivity for the ...
Business Wire15d
Neurotech’s ENCELTO™ (revakinagene taroretcel-lwey) Approved by the FDA for the Treatment of Macular Telangiectasia Type 2 (MacTel)
ENCELTO is the first and only FDA-approved treatment available for MacTel. The approval was based on results from two phase 3 trials which demonstrated that after placement, of the implant ...
The American Journal of Managed Care8d
Uniform Global Standards, Processes Could Accelerate CGT Approvals, Access
The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.
Travere Therapeutics submits sNDA to FDA for approval of FILSPARI in FSGS
Travere Therapeutics (TVTX) has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking priority review ...