Regulatory submission is based on positive results from the Phase 2 PROSPECT Study —– FDA sets PDUFA Date of December 18, 2026 —OSAKA, Japan & WALTHAM, Mass.--(BUSINESS WIRE)--Deciphera ...
FDA accepted a new drug application for tirabrutinib in relapsed or refractory PCNSL.
OSAKA, Japan & WALTHAM, Mass.--(BUSINESS WIRE)--Deciphera Pharmaceuticals, LLC, a biopharmaceutical company focused on discovering, developing, and commercializing ...
Registration is now open for the “New Developments in PCNSL Treatment” online educational event on March 27th, 2026, ...
An Ono Pharma drug for a type of tumor affecting tissues of the joints is now FDA approved, giving the Japanese company a product with dosing and safety advantages over the Daiichi Sankyo product that ...
OSAKA, Japan & WALTHAM, Mass.--(BUSINESS WIRE)--Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) announced that the U.S ...
Becoming the second drug approved by the U.S. FDA for tenosynovial giant cell tumors, Deciphera Pharmaceuticals Inc.’s oral CSF1R inhibitor vimseltinib, newly branded Romvimza, could take significant ...
(RTTNews) - Deciphera Pharmaceuticals, and Ono Pharmaceutical Co. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion ...
WALTHAM, Mass.--(BUSINESS WIRE)-- Deciphera Pharmaceuticals, Inc. (Nasdaq:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, today ...
Lead the PV Sciences team, ensuring regulatory compliance in safety data analyses for investigational and marketed products while driving team strategy, mentorship, and process improvements across ...
Vimseltinib is the first and only therapy with a positive CHMP opinion for the treatment of TGCT in the European Union Deciphera Pharmaceuticals, LLC, a biopharmaceutical company focused on ...