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Avadel Pharmaceuticals Announces Unanimous Appeals Court Decision Upholding FDA Approval of LUMRYZ in Narcolepsy in Administrative Procedure Act Litigation
Globenewswire· 2025-06-30 11:00
DUBLIN, June 30, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced that, on Friday, June 27, 2025, the U.S. Court of Appeals for the District of Columbia Circuit (the "Appeals Court") affirmed a prior decision of the U.S. District Court for the District of Columbia (the "District Court") in favor of the U.S. Food and Drug Administration ("FDA") in a suit brought by Jazz Pharmaceuticals Inc. ("Jazz") ...
Avadel Pharmaceuticals Announces Favorable Ruling in Appeal of Delaware Court Injunction
Globenewswire· 2025-05-06 16:30
- With this ruling, Avadel can seek and be granted FDA approval for LUMRYZ in Idiopathic Hypersomnia - - Federal Circuit decision permits new clinical trials and further development of LUMRYZ™ for the treatment of indications beyond narcolepsy - DUBLIN, Ireland, May 06, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced that the United States Court of Appeals for the Federal Circuit (the “Fede ...