The U.S. FDA gave Nabriva Therapeutics a thumbs-up for the company’s oral and intravenous formulations of Xenleta (lefamulin) to treat community-acquired bacterial pneumonia in adults.
The EMA recommended approving Vitrakvi to tackle tumors with a specific genetic mutation regardless of where the disease started.
GW Pharmaceuticals’ marijuana-based treatment Epidyolex won a positive recommendation for marketing approval from a European Medicines Agency (EMA) panel for use as an additional treatment for two types of seizures.
The U.S. FDA gave Alexion Pharmaceuticals a thumbs-up for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder in adults that express a specific biomarker.
The U.S. Food and Drug Administration approved Pfizer Inc.’s biosimilar to Roche Holding AG’s blockbuster cancer treatment Avastin.
Vertex Pharmaceuticals Inc. will apply for regulatory approval during 2019 for the company’s triple combination of drugs to treat the life-shortening genetic condition cystic fibrosis.
San Rafael, Calif.-based BioMarin Pharmaceutical announced positive Phase III clinical trial results for the company’s gene therapy, valoctocogene roxaparvovec, for adults with hemophilia A.
The U.S. Food and Drug Administration approved Zolgensma, a gene therapy that Novartis called a life-changing medicine, for children younger than 2 years of age who have been diagnosed with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 gene.
Pfizer announced plans to buy Therachon, a rare disease biotech company based in Basel, Switzerland.
The U.S. FDA gave Sanofi SA’s dengue vaccine Dengvaxia a very narrow approval as the company continues to suffer from evidence that its vaccine can cause severe infections in some people.