Regulation

ImmunityBio, NantKwest announce positive interim phase 1 safety data of hAd5 Covid-19 vaccine dose study

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 gets FDA EUA status for bamlanivimab to treat Covid-19

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 gets FDA approval for SESQUIENT to treat status epilepticus

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.

BMS gets EC approval for Opdivo, Yervoy combo for treatment of metastatic NSCLC

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 receives US orphan drug status for NK cell-based immunotherapy in multiple myeloma

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 gets EU approval for heart failure drug Forxiga

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 gets EC nod for Adakveo to prevent pain crises in sickle cell disease patients

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.

EC approves Zejula as first-line monotherapy maintenance treatment in advanced ovarian cancer

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.

ENHERTU gets FDA priority review in HER2-positive metastatic gastric cancer

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.