Amneal and mAbxience score FDA green light for two Denosumab biosimilars

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

AB Science secures US patent for Masitinib in sickle cell disease till 2040

Masitinib targets mast cells, which play a critical role in severe forms of SCD and its complications, including vaso-occlusive crises, acute chest syndrome, and pain

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

Lunit SCOPE matches pathologist accuracy in HER2 scoring for advanced biliary tract cancer

Study published in laboratory investigation, the official journal of the United States and Canadian Academy of Pathology

India's First: Curapod wearable gets Class II nod for drug-free musculoskeletal pain relief

Provides pain relief for more than 30 conditions, including chronic back pain, arthritis, and sports injuries

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

Gilead licenses Assembly Bio's investigational Herpes drugs after positive phase 1b data

Under the 2023 collaboration agreement, Assembly Bio will receive $35 million for Gilead’s exercise of the HSV program option

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

Enveda launches Phase 1 trial for first-in-class Oral IBD therapy

The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ENV-6946 in healthy volunteers