Drug Filing

FDA grants priority review for AstraZeneca’s Calquence sNDA

The US Food and Drug Administration (FDA) has accepted and granted priority review to AstraZeneca's supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).

AbbVie seeks FDA approval for non-small cell lung cancer treatment

AbbVie has filed a biologics license application (BLA) with the US Food and Drug Administration (FDA) seeking accelerated approval for telisotuzumab vedotin (Teliso-V) in adult non-small cell lung cancer (NSCLC) patients.

FDA grants priority review for Bavarian Nordic’s chikungunya vaccine BLA

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Bavarian Nordic's chikungunya virus vaccine candidate, CHIKV VLP, granting it priority review status.

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).