Biocon Biologics secures market entry date for Denosumab biosimilars in Europe, Rest of the World

The agreement allows Biocon Biologics to commercialize both its Denosumab biosimilars (Vevzuo and Evfraxy) in Europe starting December 2, 2025

US District Court grants summary judgement in Favour of SPARC for Sezaby PRV

FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved'

Belite Bio reports landmark phase 3 success for Stargardt Disease therapy

Seeing well-controlled Phase 3 data that shows a marked slowing of lesion growth in Stargardt disease is deeply encouraging

LENZ Therapeutics, Lotus Pharmaceutical submit NDA for presbyopia treatment in Korea

Presbyopia, the age-related loss of near vision, could soon be treated successfully

Cleveland Diagnostics’ IsoPSA test for prostate cancer detection gains FDA approval

Now a test that offers new precision in prostate cancer detection

Bayer welcomes US Solicitor General’s support as Supreme Court weighs Roundup case

At the heart of the showdown is a deep split among federal circuit courts over whether federal law overrides state failure-to-warn claims in Roundup personal-injury suits

Lupin receives FDA approval for biosimilar Armlupeg

Armlupeg is indicated for decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs

Roche expands Veeva partnership with global rollout of AI-driven Vault CRM

Roche says the move marks a step forward in its digital transformation strategy

OSR Holdings moves towards major licensing deal for oral cancer immunotherapy

Under the proposed terms, Vaximm would secure a $20 million upfront payment, up to $815 million tied to clinical, regulatory, and commercial milestones

SK Biopharmaceuticals acquires exclusive global rights for WARF cancer drug candidate