Novartis2d
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 ...
clinicaladvisor.com15d
FDA Approves First Generics of Anticoagulant Xarelto
The approval is only for the 2.5mg tablet. The Food and Drug Administration (FDA) has approved the first generics of Xarelto ® (rivaroxaban) 2.5mg. Xarelto 2.5mg is used, in combination with ...
Policy & Medicine20d
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 Wire26d
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 ...
Monthly Prescribing Reference17d
FDA Approves Encelto for Macular Telangiectasia Type 2
Encelto, the first FDA-approved treatment for MacTel, is implanted intravitreally during a surgery performed by a qualified ophthalmologist. The Food and Drug Administration (FDA) has approved ...
The American Journal of Managed Care9d
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.