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.
Star Therapeutics' investigational monoclonal antibody, VGA039, has gained fast track designation from the US Food and Drug Administration (FDA) for the treatment of von Willebrand disease (VWD).
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.
Torii Pharmaceutical has submitted a new drug application (NDA) for TO-208 in Japan, targeting the treatment of molluscum contagiosum, a common and highly contagious skin disease.
The Japanese Ministry of Health, Labour, and Welfare (MHLW) has granted orphan drug designation to Renalys Pharma’s sparsentan, which is intended for the treatment of primary IgA nephropathy (IgAN).
The China’s National Medical Products Administration (NMPA) has granted marketing authorisation to Sichuan Kelun-Biotech Biopharmaceutical’s sacituzumab tirumotecan (sac-TMT), a domestically developed trophoblast cell surface antigen 2 (TROP-2)-directed antibody-drug conjugate (ADC) for the treatment of the adult population with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).
Mirum Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to its drug candidate, volixibat, for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC).
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