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Complete Response Letter
Biotech
Vanda receives FDA rejection, issues fiery response
The biotech came out swinging after the blow, accusing the FDA of sending a complete response letter that generally disregarded the evidence.
Nick Paul Taylor
Sep 19, 2024 8:02am
FDA rejects Regeneron bispecific, delaying rival to J&J, Pfizer
Aug 21, 2024 5:48am
Lykos' MDMA treatment for PTSD has been quashed at the FDA
Aug 10, 2024 9:07am
Aldeyra preps for FDA refiling as dry eye drug hits ph. 3 goal
Aug 8, 2024 10:48am
Rocket gene therapy's flight to approval delayed by FDA
Jun 28, 2024 9:58am
Milestone resubmits NDA, Aldeyra readies 2nd chance filing
Mar 28, 2024 10:40am
