Epidiolex Gets Priority Review for Tuberous Sclerosis Complex-Associated Seizures
The FDA has accepted for Priority Review the supplemental New Drug Application for Epidiolex.
The FDA has accepted for Priority Review the supplemental New Drug Application for Epidiolex.
According to the results of tests conducted by the Agency, NDMA levels in ranitidine products can increase over time under normal storage conditions.
The FDA has approved an expanded indication for the gammaCore device to include prevention of migraine.
The decision to stop the trial was made based on positive efficacy data following a recommendation from the study’s independent DMC.
Biohaven announced positive topline results from a pivotal phase 2/3 study evaluating rimegepant for the preventive treatment of episodic and chronic migraine in adults.
Eyevance announced the launch of Zerviate™ (cetirizine ophthalmic solution) 0.24% for the treatment of ocular itching associated with allergic conjunctivitis in patients 2 years of age and older.
“This is the first phase 3 study to demonstrate that a PCSK9 inhibitor can effectively and safely reduce LDL-C in people living with HIV at risk for cardiovascular disease who have high cholesterol level despite statin treatment,” said Professor Franck Boccara, MD, PhD, cardiologist and primary study investigator.
Xarelto, a Factor Xa inhibitor, is currently indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
The FDA has approved the New Drug Application for Triferic AVNU®.
The FDA has approved the supplemental Biologics License Application (sBLA) for Taltz (ixekizumab: Lilly) injection for the treatment of pediatric patients aged ≥6 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.