Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved transseptal mitral valve replacement
The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR
The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR
The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies
Shonan iPark was chosen for its globally connected life-science ecosystem, which unites pharmaceutical firms, next-generation medicine developers, AI and digital health innovators, venture capital, and academia
Production at Biocon Biologics’ own facilities is scheduled to begin once technology transfers and regulatory approvals are finalized
GSK will make most of its inhaled respiratory portfolio and other products available on a direct purchasing platform, offering savings of up to 66%
Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026
The initiative is focused on a problem that continues to plague cancer outcomes in India
The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation
The funding will support the pivotal Phase 3 clinical trial of neridronate in CRPS-1
The approval of Nuzolvence (zoliflodacin) follows a collaborative development effort with the Global Antibiotic Research and Development Partnership
Subscribe To Our Newsletter & Stay Updated