The approval is supported by bioequivalence data assessing the once-daily extended-release formulation to twice-daily immediate-release ruxolitinib in healthy participants.
FDA cleared once-daily ruxolitinib XR for MF, HU-refractory/intolerant PV, and steroid-refractory acute/chronic GVHD after ...
Indications span MF and PV in adults, plus acute/chronic GVHD in patients ≥12 years, positioning XR as a once-daily ...
RARITAN, N.J., Aug. 26, 2011 /PRNewswire via COMTEX/ -- Janssen Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved NUCYNTA® ER, an oral analgesic taken ...
PRINCETON, N.J. & LONDON--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) approved KOMBIGLYZE ™ ...
Oral NMDA receptor antagonist gets an expanded indication ...
Pfizer Inc. announced today that the U.S. Food and Drug Administration has approved XELJANZ ® XR extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately ...
In a recent study published in the journal Nature Medicine, an international team of researchers evaluated the efficacy, safety, and tolerability of extended-release ketamine tablets (R-107) in adult ...
CONSHOHOCKEN, PA and VANCOUVER, BC, March 23 /PRNewswire/ - Neuromed Pharmaceuticals, Inc. today announced positive results of a pivotal phase 3 clinical trial of its lead investigational drug, Exalgo ...
Patients prescribed the 30mg dose who receive the 60mg dose may potentially be at risk for overdose and death. Bryant Ranch Prepack Inc. has voluntarily recalled 1 lot of Morphine Sulfate 30mg ...