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FDA application process
Biotech
Reata has wait for FDA ataxia drug decision delayed by 3 months
Reata has done its homework in responding to the FDA’s concerns about an application for its nerve disorder drug, but will now have to wait longer.
James Waldron
Aug 9, 2022 9:52am
TG's pivot to MS faces setback as FDA pushes approval
May 31, 2022 9:40am
Incyte pulls approval filing, following Gilead out of the exitIn
Jan 26, 2022 7:30am
Biogen, Sage plot 2022 filing for zuranolone approval
Oct 19, 2021 7:50am
Merck seeks FDA nod for COVID antiviral 10 days after data drop
Oct 11, 2021 7:45am
Ipsen’s $1B bet on rare disease drug suffers another setback
Aug 13, 2021 7:30am