Regulation

Star Therapeutics’ von Willebrand disease therapy gains FDA fast track status

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).

China’s NMPA approves Astellas’ advanced gastric cancer combo therapy

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 NMPA approves Innovent’s taletrectinib for NSCLC treatment

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).

FDA approves BeiGene’s TEVIMBRA combo for treating certain gastric cancers

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 submits NDA for molluscum contagiosum treatment therapy in Japan

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.

Japan MHLW grants orphan drug status to Renalys’ sparsentan for IgAN treatment

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).

China’s NMPA grants marketing approval to Kelun-Biotech’s sac-TMT for TNBC treatment

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).

Volixibat gains FDA breakthrough therapy designation

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).

Neuvivo files NDA seeking FDA approval for ALS treatment

Neuvivo has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) seeking approval for its investigational treatment NP001for treating amyotrophic lateral sclerosis (ALS).