Iovance Biotherapeutics has completed submission of the Biologics License Application (BLA) for lifileucel to the US Food and Drug Administration (FDA).
27 Mar 2023
21 Feb 2023
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.
29 Dec 2022
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.
31 Oct 2022
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).
24 Oct 2022
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).
31 Aug 2022
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.
27 Jun 2022
The US Food and Drug Administration (FDA) has agreed to review Emergent BioSolutions’ Biologics License Application (BLA) for AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted).
15 Mar 2021
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.
03 Feb 2021
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.
13 Jan 2021
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).