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Complete Response Letter
Biotech
FDA rejects Applied filing for rare disease approval
Applied said the complete response letter cited “deficiencies in the clinical application,” but it plans to reapply or appeal.
Nick Paul Taylor
Dec 2, 2024 5:27am
Vanda receives FDA rejection, issues fiery response
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
