AstraZeneca and Daiichi Sankyo's ENHERTU (fam-trastuzumab deruxtecan-nxki) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Pfizer announced that the U.S. Food and Drug Administration (FDA) accepted for filing and granted Priority Review designation to the company’s New Drug Application (NDA) for abrocitinib (100mg and 200mg), an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in patients 12 and older.
Kala Pharmaceuticals, a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that the US Food and Drug Administration (FDA) has approved EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.
Novartis has secured orphan drug designation from the European Medicines Agency (EMA) for its oral, small molecule iptacopan (LNP023) in IgA nephropathy (IgAN).
The US Food and Drug Administration (FDA) has approved Gilead Sciences’ antiviral drug Veklury (remdesivir) for the treatment of Covid-19 in patients needing hospitalisation.
Novartis has secured orphan drug designation from the US Food and Drug Administration (FDA) for its branaplam (LMI070) to treat Huntington’s disease (HD).
AstraZeneca’s TAGRISSO (osimertinib) has received acceptance for its supplemental New Drug Application (sNDA) and has also been granted Priority Review in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent.
Xeris Pharmaceuticals, a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, announced it was granted fast track designation by the Food and Drug Administration (FDA) for the investigation of XP-0863 (diazepam non-aqueous injection) for the treatment of acute repetitive seizures.
Astellas Pharma has secured fast track status from the US Food and Drug Administration (FDA) to develop ASP0367/MA-0211 (ASP0367) as a potential treatment for primary mitochondrial myopathies (PMM).
Versantis AG, a clinical-stage company developing novel therapies for orphan liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted a rare pediatric disease designation (RPDD) to its lead product candidate VS-01, an ammonia clearance enhancer, for the treatment of Urea Cycle Disorders (UCD).
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