Mabwell’s Mailisheng receives NMPA marketing approval
Mabwell has announced that its Albipagrastim alfa for Injection (Mailisheng) received marketing approval from the National Medical Products Administration (NMPA).
Mabwell has announced that its Albipagrastim alfa for Injection (Mailisheng) received marketing approval from the National Medical Products Administration (NMPA).
Archeus Technologies has announced a strategic collaboration with the Wisconsin Alumni Research Foundation (WARF) to advance ART-101 for prostate cancer.
The US Food and Drug Administration (FDA) has granted fast track designation to Zai Lab’s delta-like ligand (DLL3) antibody-drug conjugate (ADC), ZL-1310, for treating extensive-stage small cell lung cancer (ES-SCLC).
The University of Calgary and Alberta Children’s Hospital have secured C$68,000 ($48,694) from Brain Cancer Canada for a research initiative spearhead by Dr Patrick Sipila and Dr Aru Narendran, aimed at improving outcomes for children with aggressive brain cancers.
BrainChild Bio's B7 homolog 3 (B7-H3) targeting autologous chimeric antigen receptor (CAR) T-cell therapy, BCB-276, has received the regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration (FDA) for treating diffuse intrinsic pontine glioma (DIPG).
InnoCare’s B-cell lymphoma-2 (BCL2) inhibitor, Mesutoclax (ICP-248), has secured breakthrough therapy designation (BTD) from the China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE).
Roche has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for updating the European Union (EU) label of Phesgo.
Pharmaceutical company Er-Kim has entered into an agreement with Puma Biotechnology for the distribution of the latter’s Nerlynx (neratinib), aimed at treating breast cancer, in certain Central Asian and Eastern European countries.
Tempus AI has entered into strategic partnerships with AstraZeneca and Pathos AI to develop a multimodal foundation model in oncology.
Ensem Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for ETX-636.