Avadel stock rises 8% as FDA grants tentative approval to its Jazz's sleep disorder drug rival [Seeking Alpha]
Jazz Pharmaceuticals plc - Ordinary Shares (JAZZ)
Last jazz pharmaceuticals plc - ordinary shares earnings: 2/25 04:05 pm
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Avadel stock rises 8% as FDA grants tentative approval to its Jazz's sleep disorder drug rivalJul. 19, 2022 8:58 AM ETAvadel Pharmaceuticals plc (AVDL)JAZZBy:RavikashSA News Editor2 CommentsGrandbrothersThe U.S. Food and Drug Administration (FDA)grantedNASDAQ:The company said the final approval for Lumryz, also known as FT218, is pendingdisposition of a U.S. patent, No. 8,731,963 (the 'REMS patent').The patent in question was granted to Jazz Pharmaceuticals' (REMS (Risk Evaluation and Mitigation Strategy)according to the FDAThe '963 patent allegedly covered using a computer-implemented system which addressed certain FDA-required REMS conditions of using Xyrem as per the label, according to areportAvadel said in a July 19 press release that it has filed a motion in the U.S. District Court for the District of Delaware on June 23, to delist the REMS patent from FDAâ??s Orange Book.The company added that the tentative approval suggests that Lumryz met all required quality, safety, and eff
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JAZZ
News
- Jazz Pharmaceuticals to Present Data Across Growing Oncology Pipeline and Portfolio at ASCO 2024 [Yahoo! Finance]Yahoo! Finance
- Jazz Pharmaceuticals to Present Data Across Growing Oncology Pipeline and Portfolio at ASCO 2024PR Newswire
- Jazz Pharmaceuticals (JAZZ) Earnings Expected to Grow: What to Know Ahead of Next Week's Release [Yahoo! Finance]Yahoo! Finance
- Jazz Pharmaceuticals Employees Wear Purple To Support Epilepsy Awareness and Community [Yahoo! Finance]Yahoo! Finance
- Jazz Pharmaceuticals to Report 2024 First Quarter Financial Results on May 1, 2024PR Newswire
JAZZ
Earnings
- 2/28/24 - Beat
JAZZ
Sec Filings
- 4/9/24 - Form 4
- 3/8/24 - Form 4
- 3/7/24 - Form 4
- JAZZ's page on the SEC website