Top Regulatory News Stories – Week Ending October 19, 2018

The US FDA approved Pfizer’s PARP inhibitor, Talzenna (talazoparib), for patients with a germline BRCA-mutated (gBRCAm), HER2-negative breast cancer. The agency also approved Myriad Genetics’ diagnostic assay to identify the mutation. Novartis reported it received a Complete Response Letter from the FDA for canakinumab as a potential treatment for cardiovascular risk reduction. Ocular[…]