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 ...

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 ...

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 ...

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 ...

(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 ...

After a drawn-out approval process, medical equipment company Baxter International received regulatory clearance for a new infusion pump machine that is expected to help the company capture more of ...