Epkinly breaks ground in Phase III FL trial
Genmab and AbbVie’s subcutaneous bispecific antibody Epkinly (epcoritamab) has met its dual primary endpoints as a second-line combination therapy in…
Genmab and AbbVie’s subcutaneous bispecific antibody Epkinly (epcoritamab) has met its dual primary endpoints as a second-line combination therapy in…
Alfasigma plans to engage with regulators to seek approval for Jyseleca (filgotinib) in active axial spondyloarthritis (axSpA) following a successful…
After two weeks in the regulatory wringer, Sarepta Therapeutics has been given clearance to continue shipments of its Duchenne muscular…
Sarepta has suffered another regulatory setback after the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP)…
Danish weight-loss giant Novo Nordisk has lost a US patent to generics manufacturer Viatris. A federal district court in Delaware…
The UK Government has passed legislation to decentralise the manufacture of personalised medicines, allowing them to be prepared in facilities…
Sarepta Therapeutics has yielded to the US Food and Drug Administration (FDA), agreeing to suspend shipments of Elevidys (delandistrogene moxeparvovec)…
Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the US Food and…
The US Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK’s Blenrep (belantamab…
The White House’s decision to safeguard $400m in President's Emergency Plan for AIDS Relief (PEPFAR) funding to support the global…