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Lancet Neurology Publishes Positive, Pivotal Phase 3 Data of Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia

January 5, 2022

/PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced positive data from the Phase 3 multicenter, placebo-controlled, double-blind,...

United States Dauvilliersy Arnulf Kristin Bhavnani Andrean Flynn Rob Iannone Yves Dauvilliers

Source: prnewswire.com

Lancet Neurology Publishes Positive, Pivotal Phase 3 Data of Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia

January 5, 2022

/PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced positive data from the Phase 3 multicenter, placebo-controlled, double-blind,...

United States Dauvilliersy Arnulf Kristin Bhavnani Andrean Flynn Rob Iannone Yves Dauvilliers

Source: prnewswire.com

Jazz Pharmaceuticals plc: Lancet Neurology Publishes Positive, Pivotal Phase 3 Data of Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia

January 5, 2022

Treatment with Xywav resulted in clinically meaningful improvement in idiopathic hypersomnia symptoms, including excessive daytime sleepiness, sleep inertia and prolonged sleep duration with

United States Dauvilliersy Arnulf Kristin Bhavnani Andrean Flynn Rob Iannone Yves Dauvilliers

Source: finanznachrichten.de

Recorlev Approved to Treat Endogenous Hypercortisolemia in Cushing Syndrome

January 4, 2022

The FDA has approved Recorlev (levoketoconazole) for the treatment of endogenous hypercortisolemia in adults with Cushing syndrome.

Xeris Biopharma Drug Administration Boxed Warning

Source: empr.com

U.S. FDA Grants Orphan Drug Exclusivity (ODE) for Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia in Adults

January 3, 2022

/PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Exclusivity...

United States Robert Iannone Kristin Bhavnani Andrean Flynn American Psychiatric Association Jazz Pharmaceuticals Inc

Source: prnewswire.com

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Jazz Pharmaceuticals plc: U.S. FDA Grants Orphan Drug Exclusivity (ODE) for Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia in Adults

January 3, 2022

ODE for IH for adults follows June 2021 grant of ODE for treatment of cataplexy or excessive daytime sleepiness in patients 7 years and older with narcolepsy DUBLIN, Jan. 3, 2022 /PRNewswire/

United States Robert Iannone Kristin Bhavnani Andrean Flynn American Psychiatric Association Jazz Pharmaceuticals Inc

Source: finanznachrichten.de

New FDA Study Shows Benzodiazepines Can Cause Long-Term Injury

December 24, 2021

The FDA has finally acknowledged the harmful effects of benzodiazepines and the dangers of withdrawal.

United Kingdom Leo Hollister Steven Wright Malcolm Lader Bernie Silvernail Heather Ashton

Source: madinamerica.com

DURECT and Innocoll Announce a $136 Million U.S. Licensing Agreement for POSIMIR® (Bupivacaine Solution)

December 22, 2021

/PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced a licensing agreement granting Innocoll Biotherapeutics plc, a specialty pharmaceutical...

United States Innocoll Biotherapeutics Louis Pascarella Jamese Brown Drug Administration Innocoll Pharmaceuticals

Source: prnewswire.com