EMA Recommends an Extension of Indications for Olaparib
New indication concerns treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer
Oncology News
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1533 results
FDA Approves New Formulation of Herceptin for Subcutaneous Use
Approval is based on results from two randomised trials, HannaH and SafeHER
FDA Approves Trifluridine/Tipiracil for Recurrent, Metastatic Gastric and Gastro-oesophageal Junction Adenocarcinoma
Approval is based on results from the TAGS trial
FDA Approves Pembrolizumab for Adjuvant Treatment of Melanoma
Approval is based on results from the EORTC1325/KEYNOTE‑054 study
Neoadjuvant PD-1 Blockade in Glioblastoma
Evaluation of changes in the tumour immune microenvironment
Role of Big Data for Evaluation and Supervision of Medicines in the EU
Summary report of the Heads of Medicines Agencies – EMA Joint Big Data task force
Two Health Consortia to Develop a Detailed Feasibility Proposal for Europe’s Next €1-billion Science Projects
LifeTime and RESTORE among shortlisted projects
NICE Develops a Medtech Innovation Briefing on Axumin
Axumin is a radiopharmaceutical agentfor functional imaging of prostate cancer recurrence
Gustave Roussy and Institut Bergonié, Partners for Early Phase Trials and Therapeutic Innovation in Oncology
Increase in accrual capacity and the quality standards
Withdrawal of the EU Marketing Authorisation Applications for Cavoley and Efgratin
Both contain the active substance pegfilgrastim and were developed as a biosimilar medicine
FDA Approved Caplacizumab-yhdp
Approval is based on results from the HERCULES trial
Companies That Make Sartan Medicines Should Review Their Manufacturing Processes to Avoid Presence of Nitrosamine Impurities
Recommendations follow EMA’s review of substances classified as probable human carcinogens