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 ...
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) ...
The U.S. Infusion Therapy Device Market is on an upward trajectory. By 2029, the market is predicted to exceed $3.6 billion. Rising healthcare costs led to increased demand for infusion therapy ...
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 ...
(RTTNews) - Supernus Pharmaceuticals Inc. (SUPN) said that the U.S. Food and Drug Administration has acknowledged the resubmission of the new drug application or NDA for its SPN-830, an apomorphine ...
Supernus Pharmaceuticals (NASDAQ:SUPN) shares dipped ~11% premarket on Monday after the U.S. drug regulator rejected its experimental apomorphine infusion device for the continuous treatment of motor ...
For the fourth time already this month, the FDA has issued a notice formally bestowing a Class I label—denoting a heightened risk of serious injury or death—upon a recall of yet another drug delivery ...
Questions about an infusion device have scuttled Supernus Pharmaceuticals’ attempt to win approval of a Parkinson’s disease therapy. The complete response letter marks the second time in two years ...
Catheter and infusion-device assembly are among the manufacturing processes that can be performed quickly and at low cost with the use of UVCAs. Christine M. Salerni Both low- and high-viscosity UVCAs ...
LONDON (Reuters) - Privately held company CeQur, which is developing the world’s first three-day insulin infusion device for people with type 2 diabetes, has raised $100 million in a funding round ...