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

FDA okays AQVESME as first treatment for anemia in alpha- & beta-thalassemia

The approval makes AQVESME the only FDA-approved therapy for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia

FDA nod to Boehringer Ingelheim’s JASCAYD for progressive pulmonary fibrosis in adults

The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo

Abbott’s Volt PFA System gets FDA nod

AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life

FDA go-ahead to Roche’s one-minute follicular lymphoma therapy

Full approval will depend on verification of clinical benefit in a confirmatory trial

FDA nod to MYQORZO for obstructive hypertrophic cardiomyopathy

The drug is designed to improve functional capacity and reduce symptoms by inhibiting cardiac myosin motor activity

Abbott wins FDA & CE nod for groundbreaking premature infant heart device

The system is intended for some of the tiniest patients—premature infants weighing as little as two pounds

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

Merck strikes historic deal with Trump admin to lower drug costs for Americans

GSK’s Exdensur gains FDA nod for severe asthma with just two doses a year

The approval for Exdensur (depemokimab-ulaa) comes on the back of SWIFT-1 and SWIFT-2 Phase III trials