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ODAC
FDA cancels ODAC meeting this week to review two more dangling accelerated approvals — but won't explain why
Endpoints
Tue, 11/30/21 - 11:32 pm
FDA
ODAC
cancer
accelerated approvals
Secura Bio
Acrotech Biopharma
Incyte’s PD-(L)1 inhibitor headed for an ODAC showdown next month
Endpoints
Thu, 05/13/21 - 12:06 pm
Incyte
FDA
ODAC
anal cancer
retifanlimab
Keytruda should lose stomach cancer indication, says ODAC
Pharmaforum
Fri, 04/30/21 - 11:09 am
Merck
Keytruda
ODAC
gastric cancer
stomach cancer
Merck, Roche and Bristol Myers nab 4 of 6 positive ODAC votes for ‘dangling’ accelerated approvals
Endpoints
Thu, 04/29/21 - 10:55 pm
Merck
Roche
Bristol Myers Squibb
FDA
ODAC
accelerated approvals
Keytruda
Opdivo
Tecentriq
ODAC votes to keep Keytruda and Tecentriq accelerated approvals in bladder cancer
Endpoints
Wed, 04/28/21 - 10:12 pm
FDA
ODAC
accelerated approvals
Merck
Keytruda
Roche
Tecentriq
ODAC backs delay for Karyopharm’s selinexor
BioCentury
Tue, 02/26/19 - 11:43 pm
Karyopharm Therapeutics
ODAC
Selinexor