FDA grants Novartis’ ianalumab breakthrough therapy status for Sjögren’s disease
Novartis has announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to ianalumab, a treatment…
16 Jan 2026
FDA prevails over EMA in 2025 novel drug approvals
The US Food and Drug Administration (FDA) has once again bested the European Medicines Agency (EMA) in terms of new drug approvals in 2025, the latter agency’s Human Medicines in…
16 Jan 2026
J&J’s Caplyta doubles remission rate in MDD patients
Johnson & Johnson’s (J&J) Caplyta (lumateperone) plus antidepressants nearly doubled the likelihood of remission after six weeks, with benefit remaining for more than six months in patients with major depressive…
16 Jan 2026
UK’s MHRA gives high-dose Wegovy the go-ahead in obesity
In a landmark move for UK patients with obesity, the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the maximum 7.2mg dose of Novo Nordisk’s Wegovy (semaglutide) for chronic…
16 Jan 2026
InterAx and Alveus collaborate on small-molecule metabolic treatment
InterAx Biotech has entered a strategic research collaboration and licensing agreement with Alveus Therapeutics to develop a differentiated small-molecule therapeutic candidate for metabolic disease. Financial details of the transaction have…
16 Jan 2026
Agenus and Zydus complete $141m BOT+BAL immunotherapy collaboration deal
Agenus has completed a $141m strategic collaboration with Zydus Lifesciences to accelerate the global development and potential commercialisation of its botensilimab and balstilimab (BOT/BAL) immunotherapy combination programme. The collaboration secures…
15 Jan 2026
JPM26: Fujifilm’s modular manufacturing answer to pharma tariffs
Fujifilm Biotechnology’s system of setting up similar manufacturing facilities across the globe —termed the ‘KojoX’ approach — has allowed the contract development and manufacturing organisation (CDMO) and its partners to…