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, in partnership with its worldwide subsidiaries operating under the brand Accord, has acquired Udenyca (pegfilgrastim) from Coherus BioSciences.
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.
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.
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 has received the European Medicines Agency’s (EMA) orphan designation for CAN-2409 (aglatimagene besadenovec) to treat pancreatic cancer.
SpringWorks Therapeutics, part of Merck KGaA in Darmstadt, Germany, has received conditional marketing authorisation from the European Commission (EC) for Ezmekly (mirdametinib).
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.
Mabwell’s wholly-owned subsidiary T-mab has signed an agreement with Qilu Pharmaceutical for Albipagrastim alfa for Injection.
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.
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