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1270 News Found

Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved transseptal mitral valve replacement
Medical Device | December 27, 2025

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


Japan nod to Dupixent for children with severe asthma
Drug Approval | December 26, 2025

Japan nod to Dupixent for children with severe asthma

The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies


Asahi Kasei Pharma to move R&D hub to Shonan iPark in 2027
News | December 24, 2025

Asahi Kasei Pharma to move R&D hub to Shonan iPark in 2027

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


Biocon Biologics expands FKB deal to secure global rights for Adalimumab biosimilar
News | December 23, 2025

Biocon Biologics expands FKB deal to secure global rights for Adalimumab biosimilar

Production at Biocon Biologics’ own facilities is scheduled to begin once technology transfers and regulatory approvals are finalized


GSK strikes deal with US to lower prescription drug costs & boost respiratory medicine access
News | December 22, 2025

GSK strikes deal with US to lower prescription drug costs & boost respiratory medicine access

GSK will make most of its inhaled respiratory portfolio and other products available on a direct purchasing platform, offering savings of up to 66%


Alvotech, Teva secure US settlement with Regeneron for Eylea biosimilar launch
News | December 21, 2025

Alvotech, Teva secure US settlement with Regeneron for Eylea biosimilar launch

Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026


Replacing confusion with clarity: Global Cancer Care launches Mumbai ops to tackle detection delays
News | December 21, 2025

Replacing confusion with clarity: Global Cancer Care launches Mumbai ops to tackle detection delays

The initiative is focused on a problem that continues to plague cancer outcomes in India


Qihan Biotech launches first-in-human trial of off-the-shelf CAR-T therapy for refractory lupus
Clinical Trials | December 21, 2025

Qihan Biotech launches first-in-human trial of off-the-shelf CAR-T therapy for refractory lupus

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


Ambros Therapeutics launches with $125 million to advance breakthrough therapy for rare pain disorder
News | December 19, 2025

Ambros Therapeutics launches with $125 million to advance breakthrough therapy for rare pain disorder

The funding will support the pivotal Phase 3 clinical trial of neridronate in CRPS-1


FDA nod to first oral single-dose treatment for gonorrhea
Drug Approval | December 16, 2025

FDA nod to first oral single-dose treatment for gonorrhea

The approval of Nuzolvence (zoliflodacin) follows a collaborative development effort with the Global Antibiotic Research and Development Partnership