Oncology

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.

Mabwell signs Albipagrastim alfa deal with Qilu Pharmaceutical

Mabwell’s wholly-owned subsidiary T-mab has signed an agreement with Qilu Pharmaceutical for Albipagrastim alfa for Injection.

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.