The FDA has accepted a New Drug Application (NDA) for Celcuity’s gedatolisib in hormone receptor positive (HR+), human ...
Gedatolisib's NDA for advanced breast cancer treatment has been accepted by the FDA, with a priority review and a PDUFA date ...
The U.S. Food and Drug Administration (FDA) has accepted a new drug application for gedatolisib in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), PIK3CA ...
FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026MINNEAPOLIS, (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: ...
Gedatolisib plus Faslodex, with or without Ibrance, improved PFS in hormone receptor-positive, HER2-negative, PIK3CA wild-type advanced breast cancer. The VIKTORIA-1 trial demonstrated significant PFS ...
Roche expects filing for up to three new molecular entities in 2026, and accelerating its pipeline through partnerships and ...
Jones spoke to MHE after presenting research at the 2026 ASCO Gastrointestinal Cancers Symposium, held Jan. 8-10, in San ...
A national clinical trial led by the Alliance for Clinical Trials in Oncology has found that abemaciclib, an oral cancer drug ...
Exclusive: DNA test means patients could be offered most effective treatment first, boosting their chances of beating the disease ...
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