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Complete Response Letter
Pharma
Outlook wins FDA appeal after formal dispute proceedings
After a formal dispute resolution process, the FDA has decided that Outlook's eye drug candidate Lytenava has shown evidence of effectiveness.
Zoey Becker
May 27, 2026 8:26am
Gilead's once-rejected hepatitis D med wins FDA nod
May 26, 2026 9:49am
AbbVie, Grace Therapeutics receive manufacturing-related CRLs
Apr 24, 2026 11:37am
Citizen petition calls on FDA to tighten up CRL disclosures
Apr 23, 2026 11:26am
Fierce Biotech
Replimune to lay off staff after 'disappointing' second rejection
Apr 10, 2026 1:56pm
Corcept wins FDA nod for relacorilant in ovarian cancer
Mar 25, 2026 3:00pm
