CNBC reports that HHS plans to appoint two new FDA deputy commissioners in hopes of exerting more influence over the agency.
Celcuity files a supplemental NDA for Revtorpyk (gedatolisib) for treating certain patients with hormone receptor positive, human epidermal growth factor receptor 2 negative), locally advanced or metastatic breast cancer with a PIK3CA mutation.
CNBC reports that HHS plans to appoint two new FDA deputy commissioners in hopes of exerting more influence over the agency.
Celcuity files a supplemental NDA for Revtorpyk (gedatolisib) for treating certain patients with hormone receptor positive, human epidermal growth factor receptor 2 negative), locally advanced or metastatic breast cancer with a PIK3CA mutation.
Friends of Cancer Research publishes two scientific articles it says demonstrate the value of circulating tumor DNA as an early endpoint in clinical trials.
FDA warns Scottsdale, AZ-based R3 Medical Companies that its Bello Bio and Regen Suppliers units are selling unapproved drugs that are unlicensed biologics being manufactured with significant CGMP violations.
