Novartis receives third FDA approval for oral Fabhalta® (iptacopan) - the first and only treatment approved in C3 glomerulopathy (C3G) Phase III study showed sustained proteinuria reduction at one ...

Alnylam Pharmaceuticals' amyloidosis drug Amvuttra received Food and Drug Administration approval for an expanded indication.

Amvuttra’s clearance in a rare form of cardiomyopathy could help Alnylam turn a regular profit — if it can wrest control of a ...

U.S. Food and Drug Administration approved Alnylam's drug to treat a rare and deadly heart disease on Thursday, allowing the ...

A bill under consideration in the legislature would position Iowa to immediately allow prescriptions of a synthetic version ...

Planned single, pivotal Phase 2/3 clinical trial, if positive, acceptable for Biological License Application (BLA) submission for Alzheimer's diseaseAlignment with FDA on proposed trial study design ...

Q4 2024 Management View CEO Linda Marban highlighted the acceptance by the FDA of Capricor's Biologics License Application (BLA) for deramiocel, targeting treatment of Duchenne muscular dystrophy (DMD ...

Capricor presented preclinical data at the 2024 American Association of Extracellular Vesicles (AAEV) Annual Meeting. The ...

Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...

The FDA has approved Purified Cortrophin Gel (repository corticotropin injection USP) in a prefilled syringe presentation.

● Type B Meeting Discussion to Accelerate XRx-026 for Gout to NDA ● ...