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.
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.
The US Food and Drug Administration (FDA) has accepted Roche’s Biologics License Application (BLA) and granted priority review for glofitamab.
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).
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 National Medical Products Administration (NMPA) has accepted Legend Biotech’s New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel).
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.
Gilead Company Kite has signed an agreement to acquire clinical-stage biotech company Tmunity Therapeutics, which is focused on next-generation CAR T-therapies and technologies, for an undisclosed sum.
Moleculin Biotech has received Fast Track designation from the US Food and Drug Administration (FDA) for WP1122 to treat Glioblastoma Multiforme (GBM), an aggressive malignant primary brain tumour.
Molecular science and technology company Caris Life Sciences (Caris) and data-driven precision biotherapeutics company Hummingbird Bioscience has announced a strategic collaboration to advance clinical development of latter’s anti-HER3 therapy, HMBD-001.
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