Approvals

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.

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.

Kala Pharmaceuticals announces FDA approval of EYSUVIS for short-term treatment of dry eye disease

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.

US FDA approves Gilead’s antiviral drug Veklury for treatment of Covid-19

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 gets FDA orphan drug status for branaplam to treat Huntington’s disease

Novartis has secured orphan drug designation from the US Food and Drug Administration (FDA) for its branaplam (LMI070) to treat Huntington’s disease (HD).