Oncology

Halda receives FDA fast track status for HLD-0915 to treat prostate cancer

Halda Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its lead development candidate, HLD-0915, aimed at treating metastatic castration-resistant prostate cancer (mCRPC).

BioDlink’s bevacizumab receives marketing approval in Colombia, Pakistan

BioDlink has received marketing approval for its bevacizumab injection biosimilar from Colombia's National Institute for Surveillance of Medicines and Foods and Pakistan's Drug Regulatory Authority of Pakistan.

Intas Pharmaceuticals acquires Udenyca from Coherus BioSciences

Intas Pharmaceuticals, in partnership with its worldwide subsidiaries operating under the brand Accord, has acquired Udenyca (pegfilgrastim) from Coherus BioSciences.

Turbine and MSD aim to advance cancer treatment through AI simulations

Turbine, a Hungarian company specialising in AI cell simulations, is set to enter a research partnership with Merck & Co (MSD) to develop virtual models of cancer patient populations.

Vivace Therapeutics’ VT3989 for mesothelioma gains FDA Orphan Drug Designation

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Vivace Therapeutics' investigational small molecule, VT3989, for the treatment of mesothelioma.

AstraZeneca’s Imfinzi gains FDA priority review

The US Food and Drug Administration (FDA) has granted priority review for AstraZeneca's Imfinzi (durvalumab) supplemental Biologics License Application (sBLA) to treat patients with resectable, early-stage, and locally advanced ((Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.

Candel Therapeutics’ CAN-2409 gains EMA orphan designation

Candel Therapeutics has received the European Medicines Agency’s (EMA) orphan designation for CAN-2409 (aglatimagene besadenovec) to treat pancreatic cancer.

EU approves SpringWorks’ Ezmekly for neurofibromatosis type 1 treatment

SpringWorks Therapeutics, part of Merck KGaA in Darmstadt, Germany, has received conditional marketing authorisation from the European Commission (EC) for Ezmekly (mirdametinib).

Daiichi Sankyo and AstraZeneca’s Enhertu gains breakthrough therapy status

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to Enhertu, a targeted HER2-directed antibody-drug conjugate (ADC), discovered by Daiichi Sankyo and collaboratively developed and marketed along with AstraZeneca.