ORIC Pharmaceuticals (ORIC) lost ~22% in extended trading after the company reported data from a Phase 1b trial for its ...
Rinzimetostat 400 mg once daily selected as RP3D in combination with darolutamide for Himalayas-1 global Phase 3 registrational trial in ...
The FDA has approved a high-dose regimen of Biogen’s nusinersen (SPINRAZA) for the treatment of spinal muscular atrophy. 1 ...
Plus Therapeutics, Inc. has announced the initiation of the ReSPECT-LM dose optimization trial for its product REYOBIQ™ (rhenium Re186 obisbemeda) aimed at treating leptomeningeal metastases (LM).
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) ...
Plus Therapeutics, Inc. has begun treating patients in its ReSPECT-LM dose optimization trial for REYOBIQ (rhenium Re186 obisbemeda), targeting leptomeningeal metastases (LM), a severe complication of ...
Under Project Optimus, the FDA now expects oncology sponsors to evaluate multiple clinically relevant doses using the totality of the evidence and to identify the dosage that “m ...
The medical community today faces a deceptively simple question: How quickly should we act when a child’s life is on the line? I’m a pediatric oncologist, so my answer won’t surprise you — I think we ...
Summary of US Food and Drug Administration Chimeric Antigen Receptor (CAR) T-Cell Biologics License Application Approvals From a Statistical Perspective This review highlights strategies to integrate ...