A Prescription Drug User Fee Act target date of February 1, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) ...

Patients should receive training on the proper use of the delivery device prior to starting treatment. The Food and Drug Administration (FDA) has approved Onapgo™ (apomorphine hydrochloride [HCl]) for ...

Please provide your email address to receive an email when new articles are posted on . 52-week study included 85 adults with Parkinson’s and at least 3 hours/day of “off” time. At week 12, CSAI led ...

THURSDAY, Feb. 6, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only subcutaneous apomorphine infusion ...

The FDA approved an apomorphine hydrochloride infusion device (Onapgo) to treat motor fluctuations in adults with advanced Parkinson's disease, Supernus Pharmaceuticals announced on Tuesday. The ...

ONAPGO, a subcutaneous infusion device, treats motor fluctuations in advanced Parkinson's disease and launches in the U.S. in 2025. Supernus Pharmaceuticals has announced the FDA approval of ONAPGO, ...

Supernus Pharmaceuticals' ONAPGO for Parkinson’s Disease received FDA approval, providing a basis for optimism despite past regulatory challenges with SPN-830. The company is methodically planning ...

On Monday, Supernus Pharmaceuticals Inc. (NASDAQ:SUPN) announced a regulatory update for SPN-830, an investigational apomorphine infusion device under FDA review for the continuous treatment of motor ...

LONDON, Aug. 3, 2018 /PRNewswire/ -- Britannia Pharmaceuticals Ltd has announced publication of the results of the double-blind phase of the TOLEDO study in Lancet Neurology [1]. Treatment with APO-go ...

ROCKVILLE, Md., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central ...

ROCKVILLE, Md., Dec. 08, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of ...