Acadia Pharmaceuticals has announced U.S. Food and Drug Administration approval for DAYBUE STIX (trofinetide) for oral solution, a new powder-based formulation of its existing drug DAYBUE used in the treatment of Rett syndrome. The approval covers use in adult and pediatric patients two years and older and is based on bioequivalence data, not new clinical
Amgen has received approval from the United States Food and Drug Administration for Uplizna (inebilizumab-cdon) to treat adults with generalized myasthenia gravis who are anti-acetylcholine receptor or anti-muscle specific tyrosine kinase antibody positive. The greenlight makes Uplizna the first and only CD19-targeted B cell therapy approved for this patient population, introducing a twice-yearly dosing regimen
P&F Products and Features GmbH, the Austria-based cardiovascular device innovator, has secured approval from the U.S. Food and Drug Administration to initiate the TRICAV II pivotal clinical trial. The study will evaluate the TricValve Transcatheter Bicaval Valve System for severe tricuspid regurgitation, aiming to provide a minimally invasive option for patients who currently have no
Veradermics just completed pivotal trial enrollment for VDPHL01, its oral minoxidil for hair loss. Will it reshape dermatology? See what’s next.
FDA re-approves Augmentin XR under new priority program, restoring key antibiotic and signaling a turning point in U.S. drug supply strategy. Read more.
ProVerum wins FDA approval for ProVee, a permanent urethral stent for BPH offering fast recovery and no catheter. See how it could disrupt the urology device market.
Lilly’s Jaypirca met its Phase 3 target in CLL, matching Imbruvica on response rate and showing superior safety. Could this rewire frontline BTK therapy?
Medtronic’s MiniMed 780G now ships in the U.S. with Abbott’s Instinct sensor. Explore how this launch could reshape CGM-insulin system competition.