Purple Biotech has signed an agreement to acquire Immunorizon, which develops potential multi-specific T and NK cell engager oncology therapies.
03 Feb 2023
01 Feb 2023
The US Food and Drug Administration (FDA) has granted fast track designation to clinical stage company Artiva Biotherapeutics’s lead programme AB-101.
24 Jan 2023
TScan Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) applications for T-Plex, TSC-204-A0201, and TSC-204-C0702.
23 Jan 2023
Genexine has received the Korean Ministry of Food and Drug Safety’s (MFDS) fast track designation (FTD) for its first-in-class proprietary therapeutic DNA vaccine, GX-188E (tirvalimogene teraplasmid), for advanced cervical cancer.
20 Jan 2023
The US Food and Drug Administration (FDA) has granted fast track designation to Evaxion Biotech’s personalised cancer therapy, EVX-01, in combination with KEYTRUDA.
09 Jan 2023
The US Food and Drug Administration (FDA) has accepted Roche’s Biologics License Application (BLA) and granted priority review for glofitamab.
05 Jan 2023
Innovent Biologics has announced that China's National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted breakthrough therapy designation (BTD) for IBI351 (GFH925).
04 Jan 2023
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for talquetamab to treat patients suffering with relapsed or refractory multiple myeloma (RRMM).
03 Jan 2023
China’s National Medical Products Administration (NMPA) has accepted Legend Biotech’s New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel).
23 Dec 2022
Genmab has filed a Japan new drug application (JNDA) with the Ministry of Health, Labor and Welfare (MHLW) of the country for subcutaneous epcoritamab (DuoBody-CD3xCD20) to treat relapsed/refractory (R/R) large B-cell lymphoma (LBCL) patients.