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.
InnoCare Pharma has received approval from the Health Sciences Authority (HSA) of Singapore for HIBRUKA (orelabrutinib) to treat adult relapsed or refractory mantle cell lymphoma (R/R MCL) patients.
CG Oncology, an oncolytic immunotherapy company, has raised $120m through Series E financing round to advance its lead clinical programmes in bladder cancer towards FDA approval.
A clinical stage biotechnology company Immunomic Therapeutics has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for its ITI-3000 programme to treat patients with Merkel Cell Carcinoma (MCC).
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