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 set for July 17, 2026. The drug is intended for HR+/HER2–, PIK3CA wild-type ...

After noticing concerning patient survival data across multiple clinical trials, the FDA is losing confidence in the safety profile of the notoriously toxic PI3K inhibitor drug class for blood cancers ...

HOUSTON -- Two-thirds of patients with PI3K-mutant brain metastases responded to the maximum tolerated dose (MTD) of the small-molecule inhibitor paxalisib plus radiation therapy (RT), a small phase I ...

Although significant progress has been made in the treatment and management of patients with FL, several challenges remain, including the need to develop better prognostic models and markers for ...

Editor’s note: This is an automatically generated transcript. Please notify [email protected] if there are concerns regarding accuracy of the transcription. The current PI3K 3C inhibitors in use in ...

Please provide your email address to receive an email when new articles are posted on . The FDA Oncologic Drugs Advisory Committee voted Thursday in favor of randomized data to support future ...

Experts in cell signaling at the Babraham Institute have identified how prostate cancer cells achieve cell growth free from the usual growth cues and regulators. This discovery has implications for ...

Safety red flags have previously drawn the FDA’s attention to accelerated approvals given to a group of blood cancer drugs called PI3K inhibitors. But, through an upcoming expert panel discussion, the ...