Merck has secured approval from the US Food and Drug Administration (FDA) for its Keytruda plus chemotherapy to treat patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1 (combined positive score [CPS] ≥10) as determined by an FDA-approved test.
Forma Therapeutics has secured orphan drug status from the European Commission (EC) for its FT-4202 to treat sickle cell disease (SCD).
ImmunityBio, a privately-held immunotherapy company, and NantKwest, a clinical-stage, natural killer cell-based therapeutics company, today announced they have administered their second-generation bivalent, human adenovirus (hAd5) Covid-19 vaccine candidate in a Phase 1 trial with no serious adverse events (SAE) reported in the low dose cohort, safety is ongoing for the high dose cohort.
Eli Lilly has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its investigational neutralizing antibody bamlanivimab (LY-CoV555) to treat recently diagnosed Covid-19 patients.
Sedor Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved SESQUIENT (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients.
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.
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