FDA declines to approve Regeneron’s linvoseltamab amid manufacturing issues
The US Food and Drug Administration (FDA) has declined to approve Regeneron Pharmaceuticals’ multiple myeloma candidate linvoseltamab following an issue…
Oncology
-
-
Aadi axes 80% of staff after registrational Phase II trial fails
Aadi Biosciences has instituted cash-saving measures after the company decided to halt the registrational Phase II PRECISION1 trial for its…
-
Accenture invests in Earli to advance early cancer detection tech
Accenture has invested in biotechnology company Earli to advance early cancer detection technologies. Facilitated through Accenture Ventures, the investment aims…
-
NMPA approves Astellas’ PADCEV for advanced urothelial cancer
The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved Astellas’ PADCEV (enfortumab vedotin), a…
-
Daiichi Sankyo-AstraZeneca’s ENHERTU gains BTD for breast cancer
Daiichi Sankyo and AstraZeneca's ENHERTU has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for…
-
Armed with Phase III win, Incyte eyes label expansion for Monjuvi
Incyte has announced positive topline data from the Phase III inMIND trial evaluating its CD19-targeting monoclonal antibody Monjuvi (tafasitamab) in…
-
FDA accepts Deciphera’s vimseltinib NDA for priority review
The US Food and Drug Administration (FDA) has accepted for priority review the new drug application (NDA) for Ono Pharmaceutical…
-
Nuntius partners with Taiho to develop mRNA cancer therapies
UK-based biotechnology company Nuntius Therapeutics has announced a strategic collaboration agreement with Japan’s Taiho Pharmaceutical to develop next-generation messenger ribonucleic…
-
AstraZeneca’s sBLA for LS-SCLC treatment gains FDA priority review
AstraZeneca has received priority review from the US Food and Drug Administration (FDA) for its supplemental Biologics License Application (sBLA)…
-
NorthStar and Convergent expand deal for prostate cancer drug
NorthStar Medical Radioisotopes and Convergent Therapeutics have announced an expanded strategic collaboration for CONV01-α, a new treatment for prostate cancer.…
