Medivir obtains IND approval for fostrox

Rappta Therapeutics has announced an exclusive global license agreement with SpringWorks Therapeutics for RPT04402, a first-in-class molecular glue of specific Protein Phosphatase 2A (PP2A) complexes. 

ALK has announced that its European regulatory filing for ACARIZAX (house dust mite sublingual allergy immunotherapy tablet) in young children aged five to 11 has been approved by the health authorities in 21 EU countries via a type II variation procedure.

This agreement grants Synthego a global license to manufacture and distribute AstraZeneca's novel CRISPR gene editing enzyme, eSpOT-ON, recently published as engineered ePsCas9, to the worldwide research community.

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the company’s drug candidate TCP-25 for the treatment of the severe disease Epidermolysis Bullosa (EB).

The U.S. Food and Drug Administration (FDA) has accepted BioArctic’s partner Eisai’s Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosing.

Elicera Therapeutics' drug candidate ELC-100 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic neuroendocrine tumors.

AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy.