FDA reviews AstraZeneca’s Saphnelo for subcutaneous use in Lupus

A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available

China nod to Darolutamide for metastatic hormone-sensitive prostate cancer

The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT

EU green light to IntraBio’s AQNEURSA for rare neurological disease Niemann-Pick Type C

The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients

Sun Pharma gets DCGI nod to launch generic Semaglutide injection for weight loss in India

Company to launch product after the expiry of semaglutide patent in India

Akeso’s novel AS drug Gumokimab accepted for review by China’s drug regulator

This marks the second indication for which gumokimab has gained NDA review acceptance

EU clears Eylea 8 mg for retinal vein occlusion, expanding use of long-acting eye therapy

Treatment typically requires frequent injections directly into the eye—an ongoing burden for patients and health systems alike

Bayer acquires Attralus’ cardiac amyloidosis imaging agents

The deal to acquire AT-01 (124-Iodine-evuzamitide) and AT-05 (PAR-Peptide + technetium-99m) underscores Bayer’s commitment to expanding in molecular imaging and advancing precision cardiology

Bayer acquires Attralus’ cutting-edge cardiac amyloidosis imaging agents

The acquisition of AT-01 (124-Iodine-evuzamitide) and AT-05 (PAR-Peptide + technetium-99m) positions Bayer at the forefront of cardiac amyloidosis diagnostics

GSK reports breakthrough results in chronic hepatitis B trials

GSK’s Exdensur wins Japanese nod for severe asthma

The approval follows robust data from the SWIFT and ANCHOR Phase III trials