Novo Nordisk fast-tracks higher-dose obesity drug to FDA

The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway

Zydus inks licensing, commercialisation pact with RK Pharma

RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US

Teva breaks ground with EU approval for two key bone disease biosimilars

Mesoblast teams with NIH to launch pivotal trial of life-saving cell therapy in adults with severe aGvHD

The therapy -- Ryoncil (remestemcel-L-rknd) -- will be tested in adults with severe steroid-refractory acute graft-versus-host disease

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

GSK's TESARO sues AnaptysBio over alleged breach of cancer drug licence deal

Cosmo and Glenmark receives market authorization of Winlevi in Europe

Winlevi is authorized in EU for the treatment of acne vulgaris

AstraZeneca to invest $2 billion in Maryland manufacturing expansion

The multibillion-dollar Maryland expansion is part of AstraZeneca’s sweeping $50 billion global investment plan

GSK teams up with LTZ Therapeutics to launch next-generation cancer therapies

The collaboration to develop breakthrough myeloid cell engagers (MCEs) signals a bold push into a promising new frontier in cancer therapy

Piramal Pharma Solutions’ UK facility bags updated MHRA GMP certification

Grangemouth serves as PPS’s dedicated antibody-drug conjugate development and manufacturing hub