AVDL News and Press, Avadel Pharmaceuticals plc From 03/22/23

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2023-03-22 07:27:14 ET The U.S. Food and Drug Administration (FDA) approved Avadel Pharmaceuticals' ( NASDAQ: AVDL ) pre-launch activities importation requests (PLAIR) for sleep disorder therapy Lumryz. Through the PLAIR, Avadel is authorized to import unapproved drug produc...

DUBLIN, Ireland, March 22, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced that the U.S. Food and Drug Administration (“FDA”) has approved its Pre-Launch Activities ...

2023-03-12 13:42:22 ET Summary Avadel Pharmaceuticals' Lumryz has the potential to transform the narcolepsy treatment market. Avadel estimates that the total potential patient population for Lumryz could be greater than 30,000, with a market opportunity of over $3.0 billion annual...

2023-03-07 09:35:38 ET Summary Avadel's narcolepsy treatment Lumryz has tentative FDA approval pending final approval, which is delayed due to a patent dispute that has since been resolved. Lumryz is a once-at-bedtime narcolepsy treatment using Avadel's drug-delivery tech, differe...

Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) have reintroduced legislation that aims to end a loophole that at least one pharma company has used to block competition for its drugs. The bill, the Prescription Drug Competition Act, would allow the US FDA to approve drugs without a stay ...

Avadel Pharmaceuticals ( NASDAQ: AVDL ) has submitted an amendment to the FDA requesting final approval for LUMRYZ for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. This submission follows a unanimous 3-0 panel decision by the United S...

- Submitted amendment on March 1, 2023 to the LUMRYZ NDA seeking final FDA approval DUBLIN, Ireland, March 02, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that it ...

Avadel Pharmaceuticals ( NASDAQ: AVDL ) announced Friday that the company intends to seek final FDA approval for its sleep disorder therapy Lumryz as Jazz Pharma ( NASDAQ: JAZZ ) lost its appeal related to a patent dispute. The FDA has already granted tentative approval for Lu...

DUBLIN, Ireland, Feb. 08, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that members of management will participate in a fireside chat at the SVB Securities Global Biopharma Con...