The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) is not planning to hold an Advisory Committee meeting for Portola Pharmaceuticals' New Drug Application (NDA) for betrixaban.
The US Food and Drug Administration has accepted for filing of Intellipharmaceutics International’s New Drug Application ("NDA") seeking authorization to market its Rexista abuse-deterrent oxycodone hydrochloride extended release tablets in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.
Medical researchers and IBM are asking for the public's help in identifying prospective treatments for childhood cancers.
Abeona Therapeutics has secured orphan drug designation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products for its gene therapy program ABO-101 for children impacted by Sanfilippo syndrome type B (MPS IIIB).
The European Commission has granted orphan drug designation to ProMetic Life Sciences' PBI-4050 drug for the treatment of Alström Syndrome.
Sanofi has secured approval from the European Commission for Suliqua, the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.
US-based Biogen has agreed to pay Danish firm Forward Pharma $1.25bn to resolve a dispute over a patent on multiple sclerosis drug.
Heron Therapeutics has submitted its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for CINVANTI (HTX-019), a polysorbate 80-free, intravenous formulation of aprepitant for the prevention of Chemotherapy-Induced Nausea and Vomiting (CINV).
Gilead Sciences has received marketing authorization from the European Commission for Vemlidy (tenofovir alafenamide, TAF) 25 mg, a once-daily tablet for chronic hepatitis B virus (HBV) infection treatment in adults and adolescents (aged 12 years and older with body weight at least 35 kg).
Sangamo Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its genome editing product candidate, SB-318, to treat Mucopolysaccharidosis Type I (MPS I).
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