Oncology

Ensem Therapeutics’ application for ETX-636 secures FDA clearance

Ensem Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for ETX-636.

US FDA clears Calidi’s CLD-201 for clinical development in solid tumours

The US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for CLD-201, an allogeneic stem cell-based immunotherapy developed by Calidi Biotherapeutics, set to advance into clinical development for solid tumours.

Nona Biosciences and Atossa team up to discover breast cancer therapies

Nona Biosciences has entered into a research collaboration with Atossa Therapeutics for the discovery of next-generation antibody therapies for treating breast cancer.

ALX Oncology’s ALX2004 gains FDA IND clearance to treat solid tumours

ALX Oncology has received investigational new drug (IND) application clearance from the US Food and Drug Administration (FDA) for ALX2004, a new antibody-drug conjugate (ADC) aimed at treating solid tumours that express the epidermal growth factor receptor (EGFR).

FDA clears PDS Biotechnology’s Versamune MUC1 combo for mCRC

The US Food and Drug Administration (FDA) has granted clearance for PDS Biotechnology's investigational new drug (IND) application to assess Versamune MUC1 plus PDS01ADC for the treatment of unresectable, metastatic colorectal carcinoma (mCRC).

Genmab’s epcoritamab gains approval in Japan for lymphoma treatment

The Japan’s Ministry of Health, Labour and Welfare has granted approval to Genmab's Epkinly (epcoritamab) for treating individuals with relapsed or refractory (R/R) follicular lymphoma who have undergone at least two prior therapies.

US FDA approves Deciphera’s Romvimza for TGCT treatment

The US Food and Drug Administration (FDA) has granted approval for Deciphera Pharmaceuticals’ Romvimza (vimseltinib) to treat adults with symptomatic tenosynovial giant cell tumour (TGCT).

FDA to review Regeneron’s linvoseltamab BLA for multiple myeloma treatment

The US Food and Drug Administration (FDA) has accepted to review Regeneron Pharmaceuticals’ resubmitted biologics license application (BLA) for linvoseltamab to treat adults with relapsed/refractory (R/R) multiple myeloma (MM).

AdvanCell, Lilly partner on new targeted alpha therapies for cancer treatment

Radiopharmaceutical company AdvanCell has expanded its partnership with Eli Lilly and Company to advance targeted alpha therapies for the treatment of cancer.