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FDA application process
Biotech
J&J files for FDA approval of $6.5B autoimmune drug
J&J has taken another step toward realizing a return on its $6.5 billion nipocalimab bet, filing for FDA approval to challenge argenx and UCB in gMG.
Nick Paul Taylor
Aug 29, 2024 8:57am
Reata has wait for FDA ataxia drug decision delayed by 3 months
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
