New Drug Application
Biogen Plans Resubmission After FDA Declines High-Dose Spinraza for SMA, Requests More Production Information
Biogen; Spinraza; nusinersen; high dose; FDA; Complete Response Letter; spinal muscular atrophy; SMA; supplemental New Drug Application; Chemistry Manufacturing and Controls; CMC; regulatory; resubmission
Federal Appeals Court Overturns FDA Rejection of Vanda’s Hetlioz for Jet Lag Disorder
Vanda Pharmaceuticals; Hetlioz; FDA; jet lag disorder; Federal Appeals Court; supplemental New Drug Application (sNDA); regulatory law; clinical trial evidence
Aldeyra hopes new data for dry-eye disease drug will satisfy FDA
United States Food and Drug Administration, Aldeyra, reproxalap, Approved, Dry Eye Syndromes, Clinical Trials, New Drug Application
FDA Issues Complete Response Letter to Astellas for IZERVAY Supplemental New Drug Application
FDA, Astellas, IZERVAY, geographic atrophy, age-related macular degeneration, Complete Response Letter, supplemental New Drug Application
Biohaven Achieves Breakthrough in Spinocerebellar Ataxia Treatment with Positive Pivotal Study Results for Troriluzole
Biohaven, Troriluzole, Spinocerebellar Ataxia (SCA), Pivotal Study Results, Neurodegenerative Disease, FDA Submission, New Drug Application (NDA)
Biohaven Revives Troriluzole Hopes with Positive Update for Spinocerebellar Ataxia
Troriluzole, Spinocerebellar Ataxia (SCA), Biohaven Pharmaceuticals, Neurodegenerative Disorders, FDA New Drug Application (NDA), Clinical Trials, Rare Diseases
Insmed’s Stocks Skyrocket Following Triumphant Phase III Results for Brensocatib in Bronchiectasis Treatment
Insmed, brensocatib, bronchiectasis, Phase III trial, lung disease, stock surge, New Drug Application, FDA approval, market value
Minerva’s Roluperidone for Schizophrenia Symptoms Denied Approval by FDA
United States Food and Drug Administration, MFSD1 gene, Symptoms aspect, Schizophrenia, New Drug Application
FDA Awaits Final Decision on Madrigal’s Resmetirom for NASH Treatment with Priority Review and NDA Acceptance Set for March 14, 2024
Nonalcoholic Steatohepatitis, resmetirom, United States Food and Drug Administration, New Drug Application, Priority Review, Fibrosis, Liver, Liver, Madrigal’s, March 14, 2024