FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures

Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels

FDA investigates fatal case linked to rare blood disorder drug Adzynma

Adzynma, approved for both adults and children with cTTP, is a recombinant enzyme therapy designed to replace the deficient ADAMTS13 enzyme

Alvotech and Advanz Pharma secure European nod for Gobivaz, first biosimilar to Simponi

Gobivaz is authorised for adults with rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis (with or without methotrexate), axial spondyloarthritis, and ulcerative colitis

Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab

AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions

Cosmo and Glenmark receives market authorization of Winlevi in Europe

Winlevi is authorized in EU for the treatment of acne vulgaris

Roche wins EU green light for one-minute injection cancer therapy

Mankind Pharma inks licencing pact with Actimed to bring cachexia treatments to South Asia

The licence covers Actimed’s existing patents, its proprietary know-how and any future related patents, giving Mankind full control to advance the products under its own brands

EMA launches streamlined process to fast-track critical medicines, vaccines

The move is expected to be crucial during health crises

in-cosmetics Asia 2025 smashes records, draws global beauty elite

Over 700 exhibitors from APAC, Europe, the US, and beyond showcased the latest in personal care innovation

New England Biolabs unveils high-speed flu sequencing tool to bolster global outbreak surveillance

Developed in partnership with the Johns Hopkins Applied Physics Laboratory (APL), the module is built around a multi-segment RT-PCR method with integrated indexing