Oncology

FDA approves Plus Therapeutics’ Reyobiq for paediatric brain cancer

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 gets FDA approval for ART-101 application

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 partner for Keytruda biosimilar

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.

FDA grants breakthrough therapy status for Cellectar’s iopofosine I 131

Cellectar Biosciences has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for iopofosine I 131.

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).

Archeus Technologies partners with WARF to advance ART-101 for prostate cancer

Archeus Technologies has announced a strategic collaboration with the Wisconsin Alumni Research Foundation (WARF) to advance ART-101 for prostate cancer.

FDA grants fast track status to Zai Lab’s lung cancer treatment

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).

Canadian research initiative secures grant for paediatric brain cancer

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.

FDA grants RMAT to BrainChild Bio’s CAR T-cell therapy for DIPG

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).