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.”
First Antibiotic With New Mechanism of Action Approved in Almost 20 Years
Antibiotics, Approvals, Community-Acquired Bacterial Pneumonia (CABP), Emergency Departments, Emergency Rooms, European Medicines Agency (EMA), Fast Track Designation, FDA, FDA/Regulatory, Priority Review, U.S. Centers for Disease Control and Prevention, Wholesale Acquisition CostThe 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.
FDA Greenlights Soliris for Rare Autoimmune Disease
Anti-aquaporin-4 (AQP4) antibody, Approvals, Biomarkers, Central Nervous System, European Medicines Agency (EMA), FDA, FDA/Regulatory, Generalized Myasthenia Gravis (gMG), Hemolytic Uremic Syndrome, Immune System, Japanese Ministry of Health, Neuromyelitis Optica Spectrum Disorder (NMOSD), New Indications, Paralysis, Paroxysmal Nocturnal Hemoglobinuria (PNH), Vision problemsThe 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.
BioMarin’s Hemophilia A Gene Therapy Shows Promise in Clinical Trial
Analysts, Breakthrough Therapy Status, Clinical Data, Clinical Trials, European Medicines Agency, European Medicines Agency (EMA), Factor VIII Inhibitors, FDA, Gene Therapy, Hemophilia A, Orphan Drug Designation, Priority Medicines (PRIME) access, R&DSan 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.
