Drug Filing

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).

ARS Pharma’s NDA accepted for neffy to treat allergic reactions of Type I

The US Food and Drug Administration (FDA) has accepted ARS Pharmaceuticals’ (ARS Pharma) new drug application (NDA) for neffy for the emergency treatment of allergic reactions of Type I, including anaphylaxis in adults and children ≥30 kg (66 lbs).

OKYO Pharma plans to file IND with US FDA for Dry Eye Disease therapy

OKYO Pharma has announced plans to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for OK-101 to treat Dry Eye Disease (DED), in the fourth quarter (Q4) of this year.

FDA accepts Emergent BioSolutions’ anthrax vaccine candidate for review

The US Food and Drug Administration (FDA) has agreed to review Emergent BioSolutions’ Biologics License Application (BLA) for AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted).

Takeda submits New Drug Application for lanadelumab in Japan

Japan-based, R&D-driven Takeda Pharmaceutical Company Limited has submitted a New Drug Application (NDA) for lanadelumab to the Ministry of Health, Labour and Welfare (MHLW) in Japan.