Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation.
XNK Therapeutics announced it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its leading investigational drug candidate in the treatment of multiple myeloma (MM).
AstraZeneca has secured approval from the European Union (EU) for its Forxiga (dapagliflozin) to treat symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without type-2 diabetes (T2D).
Novartis has secured approval from the European Commission (EC) for its Adakveo (crizanlizumab) to prevent recurrent vaso-occlusive crises (VOCs) or pain crises in patients with sickle cell disease aged 16 years and older.
GlaxoSmithKline (GSK) announced the European Commission has approved Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as first-line monotherapy maintenance treatment for adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response following platinum-based chemotherapy.
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.
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