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Innovent's PD-1 suffered setbacks in the listing of overseas market, a paradigm for Chinese innovative drug in the global market PharmaSources/Caicai
February 22, 2022
Recently, FDA held an ODAC (Oncologic Drugs Advisory Committee) meeting around the key event in the listing application of Sintilimab, Innovent's PD-1 monoclonal antibody, in the United States.
Incyte Announces Outcome of FDA Oncologic Drugs Advisory Committee (ODAC) Meeting Reviewing Retifanlimab as a Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) firstwordpharma
June 25, 2021
ncyte (Nasdaq:INCY) today announced the outcome of a meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA), which reviewed the Biologics License Application for retifanlimab, an intravenous PD-1 inhibitor.
ODAC Votes No on Quizartinib as Relapsed/Refractory FLT3-ITD AML Treatment americanpharmaceuticalreview
May 16, 2019
Daiichi Sankyo Company announced the outcome of the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) to ...
Advisers urge FDA to delay decision on Karyopharm cancer drug pharmaphorum
February 28, 2019
Advisers to the US drugs regulator have said a decision on whether to approve Karyopharm’s multiple myeloma combination should be delayed until the results of a phase 3 trial, due late this year or in 2020.
Celltrion's Rituxan biosimilar gets unanimous backing from FDA committee pharmafile
November 20, 2018
FDA approval looks to be in reach for Celltrion, as an advisory committee for the US regulator voted unanimously to recommend Truxima, its biosimilar version of Roche’s Rituxan (rituximab), in the treatment of cancer.