Regulation - Drug Filing

Scholar Rock submits application of SMA therapy to FDA

Scholar Rock has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for muscle-targeted therapy, apitegromab, aimed at enhancing motor function in individuals with spinal muscular atrophy (SMA) who are already on SMN-targeted therapies.

Torii submits NDA for molluscum contagiosum treatment therapy in Japan

Torii Pharmaceutical has submitted a new drug application (NDA) for TO-208 in Japan, targeting the treatment of molluscum contagiosum, a common and highly contagious skin disease.

Neuvivo files NDA seeking FDA approval for ALS treatment

Neuvivo has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) seeking approval for its investigational treatment NP001for treating amyotrophic lateral sclerosis (ALS).

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.