FDA approves Takeda’s ENTYVIO SC for Crohn’s disease
Takeda Pharma`s Biologic Entyvio (vedolizumab) Receives Approval in the U.S.
AMSTERDAM, Feb. 21, 2024 /PRNewswire/ -- Polpharma Biologics, an international biotech company dedicated to the development and manufacturing of biosimilars, today announced topline results demonstrating the pharmacokinetic (PK) and pharmacodynamics (PD) comparability of its biosimilar candidate PB016 to its reference drug, Entyvio®* (vedolizumab).
U.S. FDA Approves Subcutaneous Administration of Takeda's ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis
Takeda Pharmaceutical`s Biologic Entyvio (Vedolizumab) Receives Approval in the U.S.
Investors have found a flaw in Morphic’s glittering EMERALD-1 trial. Months after raising $240 million on the back of top-line results that sent its stock soaring, the biotech has shared a fuller look at the data on its oral ulcerative colitis candidate and wiped out its earlier gains.
Takeda Announces FDA Acceptance of BLA for Subcutaneous Administration of ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease
OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) resubmission for the investigational subcutaneous (SC) administration of Entyvio® (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy with Entyvio intravenous. The resubmission is intended to address FDA feedback in a December 2019 Complete Response Letter (CRL).