The US Food and Drug Administration (FDA) has accepted under priority review Celgene's new drug application (NDA) seeking approval of enasidenib to treat patients with relapsed/refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation.
The Committee for Medicinal Products for Human Use (CHMP) has recommended approval to the European Medicines Agency (EMA) of Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) as therapy for advanced or metastatic non-small cell lung cancer (NSCLC) patients whose tumors express the BRAF V600 mutation.
The US Food and Drug Administration (FDA) has approved Valeant Pharmaceuticals International's Biologics License Application (BLA) for SILIQ (brodalumab) injection, for subcutaneous use, a monoclonal antibody that targets the IL-17 receptor for patients with moderate-to-severe plaque psoriasis.
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.
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.
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).
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.