The US Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) of Axcynsis Therapeutics’ antibody-drug conjugate (ADC), AT03-65, targeting CLDN6-positive solid tumours.
JW Therapeutics has received breakthrough therapy designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) for Carteyva (relmacabtagene autoleucel injection) to treat relapsed or refractory large B-cell lymphoma (r/r LBCL).
The US Food and Drug Administration (FDA) has granted priority review to Dizal's new drug application (NDA) for sunvozertinib aimed at treating locally advanced or metastatic non-small cell lung cancer (NSCLC) patients.
The China National Medical Products Administration (NMPA) has granted approval to Astellas Pharma’s VYLOY (zolbetuximab), a first-in-class monoclonal antibody, for use in conjunction with chemotherapy for the first-line treatment of individuals with a specific type of gastric cancer.
China's National Medical Products Administration (NMPA) has granted approval to the second new drug application (NDA) of Innovent Biologics’ ROS1 tyrosine kinase inhibitor (TKI), DOVBLERON (taletrectinib adipate capsule) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
The US Food and Drug Administration (FDA) has granted approval for BeiGene’s TEVIMBRA (tislelizumab-jsgr) for the treatment of adults with specific types of gastric cancer.
Akamis Bio has secured $60m in funding, marking the close of a Series A Prime financing round, which will propel the development of its clinical candidate, NG-350A, for treating locally advanced rectal cancer (LARC), through study.
Sanofi’s oral bioactive Bruton’s tyrosine kinase (BTK) inhibitor tolebrutinib has gained breakthrough therapy designation from the US Food and Drug Administration (FDA) for treating the adult population with non-relapsing secondary progressive multiple sclerosis (nrSPMS).
Tanner Pharma has partnered with Agenus to offer expanded access to investigational immunotherapies, botensilimab (BOT) and balstilimab (BAL), for individuals with microsatellite stable colorectal cancer (MSS CRC) and other advanced solid tumours.
The US Food and Drug Administration (FDA) has accepted Crinetics Pharmaceuticals' paltusotine new drug application (NDA) as a long-term maintenance and potential treatment for acromegaly in the adult population.
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