FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer

This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care

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

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

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

Soligenix publishes promising Phase 2a data for SGX945 in Behcet's Disease

SGX945 delivered beneficial effects in 7 of 8 patients suffering from painful oral ulcers

EMA grants orphan drug status to Sanofi’s Efdoralprin Alfa for rare lung disease

Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD

Zydus signs exclusive agreement with Myriad Genetics of US to launch cancer-risk assessment diagnostic tests in India

Lupin receives positive CHMP opinion for biosimilar Ranibizumab

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A

Godavari Biorefineries launches US biotech arm to advance novel cancer therapies

The move strengthens GBL’s clinical-stage presence in the United States

Merck’s KEYTRUDA–Padcev combo delivers survival gains in Phase 3 bladder cancer trial

Glenmark secures exclusive multi-regional rights to Aumolertinib from Hansoh Pharma

Hansoh Pharma will receive an upfront payment in the low double-digit millions