EMA
Medac, Byondis Strike Commercialization Pact for HER2-Targeted Antibody-Drug Conjugate
Byondis is hoping to launch the agent, SYD985, in the UK and EU as a treatment for HER2-positive advanced breast cancer.
Janssen Seeking European Union Approval for Zejula in HRR-Positive Prostate Cancer
The company submitted a marketing authorization application to the European Medicines Agency for the combination of Zejula, abiraterone acetate, and prednisolone.
NewStem Files FDA De Novo Submission, Gets CE Mark for Stem Cell Mutational Analysis Software
The NewStem Software Diagnostic Device screens human haploid embryonic stem cells for gene mutations involved in chemotherapy resistance.
In Brief This Week:Â Taiho Oncology, PamGene, Mursla, Autolus Therapeutics, Clovis Oncology
News items for the week of March 28, 2022.
EMA's CHMP Issues Positive Recommendation for Merck's Keytruda in PD-L1-Expressing Cervical Cancers
The European Commission will now review CHMP's opinion and decide whether to approve the Keytruda-containing regimen by the second quarter of this year.