Drug Filing

FDA accepts Exelixis’ cabozantinib sNDA for neuroendocrine tumours

The US Food and Drug Administration (FDA) has accepted Exelixis’ supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX) to treat two potential indications in advanced neuroendocrine tumours (NETs).

LEO Pharma obtains positive EMA CHMP opinion for eczema treatment

LEO Pharma has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval for Anzupgo (delgocitinib cream) for adults with moderate to severe chronic hand eczema (CHE).

FDA accepts BLA for BMS’ subcutaneous nivolumab to treat solid tumours

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) biologics license application (BLA) for the subcutaneous formulation of Opdivo (nivolumab) formulated along with Halozyme’s recombinant human hyaluronidase (rHuPH20) [referred as subcutaneous nivolumab] for previously approved solid tumour indications for the drug.

USFDA accepts NextPoint Therapeutics’s IND for NPX887

NextPoint Therapeutics has announced that its investigational new drug (IND) application has been accepted by the US Food & Drug Administration (FDA) for NPX887.

Mesoblast files applications with US FDA for HLHS therapy

Mesoblast has filed an application with the US Food and Drug Administration (FDA) seeking orphan drug and rare paediatric disease designations for its allogeneic cell therapy, Revascor (rexlemestrocel-L), to treat congenital heart disease hypoplastic left heart syndrome (HLHS).

Iovance Biotherapeutics submits BLA to FDA for advanced melanoma drug lifileucel

Iovance Biotherapeutics has completed submission of the Biologics License Application (BLA) for lifileucel to the US Food and Drug Administration (FDA).

FDA accepts Valneva’s chikungunya vaccine BLA for priority review

The US Food and Drug Administration (FDA) has finished a filing review of Valneva’s Biologics License Application (BLA) for single-shot chikungunya vaccine candidate VLA1553.

US FDA accepts BLA for Pfizer’s meningococcal vaccine candidate

The US Food and Drug Administration (FDA) has accepted for review of Pfizer’s biologics license application (BLA) for its investigational pentavalent meningococcal vaccine candidate, MenABCWY.

EMA accepts Almirall’s MAA filing for atopic dermatitis therapy

The European Medicines Agency (EMA) has accepted Almirall’s marketing authorisation application (MAA) filing for its lebrikizumab to treat moderate to severe atopic dermatitis (AD).