Oncology

US FDA grants fast track designation to Artiva’s lead programme AB-101

The US Food and Drug Administration (FDA) has granted fast track designation to clinical stage company Artiva Biotherapeutics’s lead programme AB-101.

TScan Therapeutics receives FDA clearance for IND applications

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.

Genexine receives FTD for DNA vaccine to treat advanced cervical cancer

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.

US FDA grants fast track designation to Evaxion Biotech’s personalised cancer therapy

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.

US FDA accepts Roche’s BLA for glofitamab to treat R/R LBCL

The US Food and Drug Administration (FDA) has accepted Roche’s Biologics License Application (BLA) and granted priority review for glofitamab.

Innovent announces BTD in China for NSCLC with KRASG12C mutation therapy

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).

Janssen submits MAA to European Medicines Agency for talquetamab

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).

China’s NMPA accepts Legend Biotech’s NDA for cilta-cel

China’s National Medical Products Administration (NMPA) has accepted Legend Biotech’s New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel).

Genmab files NDA for large B-cell lymphoma treatment in Japan

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.