News Madrigal closes on EU approval of first MASH treatment Madrigal Pharma could be just weeks away from becoming the first drugmaker to claim EU approval for a MASH treatment.
News EU: Trials should include pregnant subjects where possible With new guidance, the EMA is seeking to ramp up the inclusion of pregnant and breastfeeding women in clinical trials.
News Autolus closes on EU okay for leukaemia cell therapy The CHMP backed approval of Autolus' leukaemia CAR-T Aucatzyl, as well as drugs from GSK, Roche, SpringWorks, and others, at its May meeting.
Market Access The value of a partner, globally and locally A new podcast looks at recent trends related to drug approvals, as well as challenges and opportunities both small and large pharma companies face
News Italfarmaco closes on EU okay for Duchenne drug Italfarmaco's oral HDAC inhibitor Duvyzat has been recommended for approval in the EU as a treatment for Duchenne muscular dystrophy (DMD).
Digital Leveraging data, digitalisation, and artificial intelligence... In an era marked by rapid technological advancements and evolving healthcare needs, the European Medicines Agencies Network Strategy 2028 stands as a key
News FDA names a new CDER director, choosing a biotech vet The FDA has rounded out its senior leadership by naming biopharma industry executive George Tidmarsh to the role of CDER director.
Market Access The value of a partner, globally and locally A new podcast looks at recent trends related to drug approvals, as well as challenges and opportunities both small and large pharma companies face
