Oncology

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.

FDA clears Auron’s AUTX-703 IND to treat haematological malignancies

The US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application of Auron Therapeutics’ oral KAT2A/B degrader, AUTX-703, allowing it to progress through clinical development for haematological malignancies.

EMA’s CHMP recommends approval of Bristol Myers Squibb’s HCC treatment combo

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Bristol Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of unresectable or advanced hepatocellular carcinoma (HCC) in adults.

Manas AI launches to focus on cancer medicine discovery

Manas AI has officially launched for transforming new cancer medicines discovery.