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).
The US Food and Drug Administration (FDA) has accepted for review Merck's supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, plus chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and with no EGFR or ALK genomic tumor aberrations.
The US Food and Drug Administration (FDA) has granted priority review status for Bayer's supplemental New Drug Application (sNDA) for Stivarga (regorafenib) tablets for the second-line systemic treatment of patients with hepatocellular carcinoma (HCC).
Ironwood Pharmaceuticals’ new drug application (NDA) for its gout drug candidate, Duzallo, has been accepted for review by the US Food and Drug Administration (FDA).
Ionis Pharmaceuticals has reported positive data from phase 2 study of IONIS-GCGR Rx in patients with type 2 diabetes.
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