Drug Filing

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.

Ocugen signs agreement with Bharat Biotech to distribute Covid-19 vaccine in the US

Ocugen, a Pennsylvania-based pharmaceutical company, has signed an agreement with Bharat Biotech, an Indian pharma developer of COVAXIN, a Covid-19 vaccine, to distribute the vaccine in the US.

Bayer announces FDA accepts NDA and grants priority review for Finerenone for patients with CKD and T2D

Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted Priority Review for finerenone, an investigational drug for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).

GSK, MMV filing for Kozenis in paediatric populations with P. vivax malaria accepted by Australian TGA

GSK and Medicines for Malaria Venture (MMV) announced today that the Australian Therapeutic Goods Administration (TGA) accepted the submission of a Category 1 application to extend the indication of single-dose Kozenis (tafenoquine) to paediatric populations for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria.