Despite some safety concerns such as severe diarrhea, the FDA approved Puma’s breast cancer drug Nerlynx in July 2017.
Despite some safety concerns such as severe diarrhea, the FDA approved Puma’s breast cancer drug Nerlynx in July 2017. Those same safety concerns though appear to be a roadblock in gaining marketing approval from the EMA. To gain approval, the company will likely be asked to submit more data. The EMA is set to make a decision next month.
Here’s a roundup of these stories and other top FDA actions from the past month.
- Puma Sinks After the CHMP Throws a Roadblock at Breast Cancer Drug
- Baxter Announces U.S. FDA Approval of Ready-to-Use Cardiovascular Medication Bivalirudin
- FDA Approves Addition of Overall Survival Data to Amgen’s Kyprolis Label
- Teva Wins FDA Nod for TRISENOX (arsenic trioxide) Injection for First Line Treatment of Acute Promyelocytic Leukemia
- FDA Green Lights AstraZeneca, Merck’s Lynparza for Metastatic Breast Cancer
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