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.
TRACON Pharmaceuticals has reached an agreement with the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints and statistical analysis approach for the Company's Phase 3 study evaluating TRC105 for the treatment of patients with advanced angiosarcoma.
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