Tag: #drugapproval

FDA Approves Lifyorli Combo for Platinum-Resistant Ovarian Cancer, Showing Survival Gain

FDA clears Corcept’s Lifyorli with nab-paclitaxel for platinum-resistant ovarian-type cancers, the first cortisol-receptor blocker to extend survival.

#ovariancancer, #fda, #chemotherapy, #drugapproval, #oncology

FDA proposes new pathway to approve one-patient gene-editing drugs for ultra-rare diseases

New FDA draft guidance would let individualized CRISPR and RNA therapies win approval with tiny studies, using strong biology and natural-history data.

#fda, #geneediting, #raredisease, #crispr, #drugapproval