Bristol-Myers Squibb withdrew the company’s application in the European Union for the combination of Opdivo and Yervoy for the treatment of advanced non-small cell lung cancer (NSCLC) based on data from CheckMate -227.
Bayer won an endorsement from the European Union’s drug regulator for the company’s prostate cancer drug darolutamide, putting the medicine on track for approval to take on rival products from Pfizer and Johnson & Johnson.
A panel of the European medicines regulator recommended approving Novo Nordisk’s new diabetes pill Rybelsus, further boosting prospects for the Danish drugmaker with the company’s first-of-a-kind, non-injectable treatment.
Pharma companies from across the globe provide updates on their pipelines and business.
The U.S. Food and Drug Administration approved drugmaker Merck & Co.’s Ebola vaccine Ervebo, the first FDA-authorized vaccine against the deadly virus.
The European Commission granted marketing authorization to Amgen and UCB for Evenity (romosozumab) for treating severe osteoporosis in postmenopausal women at high risk of fracture.
The European Commission approved Astellas Pharma’s oral once-daily therapy Xospata as a monotherapy for treating adults with relapsed or refractory acute myeloid leukemia with a FLT3 mutation.
Johnson & Johnson’s Spravato, a nasal spray for depression and potential blockbuster medicine, won recommendation for approval from a European Medicines Agency panel.
The world’s first Ebola vaccine was recommended for approval by European drug regulators in a move hailed by the World Health Organization (WHO) as a “triumph for public health.”
Roche’s Tecentriq won European approval for use against a tough-to-treat breast cancer, helping the Swiss drugmaker to widen use of an immunotherapy that has so far been eclipsed in revenue terms by more-established rival medicines.