Population aging is reshaping the landscape of respiratory disease, with COPD, idiopathic pulmonary fibrosis, bronchiectasis, ...
In a recent review published in Genes & Diseases, researchers from Jinzhou Medical University, Technische Universität Dresden, and Helmholtz-Zentrum ...
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 ...
The FDA has accepted a New Drug Application (NDA) for Celcuity’s gedatolisib in hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2), PIK3CA wild-type advanced ...
Gedatolisib's NDA for advanced breast cancer treatment has been accepted by the FDA, with a priority review and a PDUFA date ...
The firm filed data from the Phase III VIKTORIA-1 trial, which evaluated gedatolisib with fulvestrant with or without a CDK4/6 inhibitor.
FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026MINNEAPOLIS, (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: ...
A national clinical trial led by the Alliance for Clinical Trials in Oncology has found that abemaciclib, an oral cancer drug ...
Roche expects filing for up to three new molecular entities in 2026, and accelerating its pipeline through partnerships and ...
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 ...
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