Approvals

FDA approves Amneal Pharmaceuticals’ Alzheimer’s and oncology treatments

The US Food and Drug Administration (FDA) has granted approval for Amneal Pharmaceuticals’ three medications, memantine/donepezil extended-release capsules and everolimus tablets for oral suspension, with tentative approval for rifaximin oral tablets.

FDA grants fast track status to Nacuity’s NPI-001 for retinitis pigmentosa

The US Food and Drug Administration (FDA) has granted fast track designation to Nacuity Pharmaceuticals’ NPI-001 (N-acetylcysteine amide) tablets for treating individuals with retinitis pigmentosa (RP).

Health Canada authorises Roche’s Vabysmo for certain eye conditions

Health Canada has granted authorisation to Roche Canada's Vabysmo (faricimab injection) to be used in a 6.0 mg single-use pre-filled syringe (PFS) for treating diabetic macular oedema, wet or neovascular, age-related macular degeneration (AMD), and macular oedema secondary to retinal vein occlusion (RVO).

FDA clears Axcynsis’ AT03-65 IND for CLDN6-positive solid tumours

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’ Carteyva receives breakthrough therapy status for r/r LBCL

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).

FDA grants priority review to Dizal’s sunvozertinib NDA for NSCLC treatment

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’ 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).