The US Food and Drug Administration (FDA) has granted clearance to Plus Therapeutics' Investigational New Drug (IND) application for Reyobiq (Rhenium Re186 Obisbemeda), a new radiotherapy to treat high-grade glioma (HGG) and ependymoma in children.
Archeus Technologies has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for ART-101.
Alvotech and Dr. Reddy's Laboratories are joining forces in a strategic partnership to co-develop, manufacture, and commercialise a biosimilar candidate for MSD’s Keytruda (pembrolizumab), targeting global markets.
Cellectar Biosciences has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for iopofosine I 131.
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).
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