FDA Approves Noctiva for Nocturnal Polyuria, Following Ad Comm Recommendations March 9, 2017 Serenity initially pursued an approval of Noctiva to treat the broader symptom of nocturia. Read More
OncoSec Receives Fast Track for IL-12 Therapy March 6, 2017 The company is planning a Phase IIb single-arm trial of ImmunoPulse. Read More
Zykadia Wins FDA Priority Review in First-Line Metastatic NSCLC March 3, 2017 The FDA also granted a Breakthrough Therapy designation to Zykadia. Read More
Revlimid Earns EC Approval and FDA-Expanded Indication for Multiple Myeloma Following Stem Cell Transplant March 2, 2017 The decision to approve Revlimid as monotherapy in that setting was based on the results of two cooperative group-led studies. Read More
Roche Wins EU Approval of Alecensa March 1, 2017 The conditional approval was based on data showing Alecensa shrank tumors by up to 52.2 percent. Read More
Cell Medica Granted FDA Fast Track Designation for Lymphoma Immunotherapy March 1, 2017 The product previously received Orphan Drug designations from the FDA. Read More
FDA Warning Letter to Pfizer Could Delay Approval of Copaxone Generic February 28, 2017 The generic drug’s approval hinges on whether Pfizer resolves the compliance issues cited in the warning letter. Read More
Amphastar Receives FDA Complete Response Letter for Intranasal Naloxone February 28, 2017 The agency identified issues with the human factors study, device evaluation and other items in the NDA. Read More
FDA Awards Second Orphan Drug Designation to Zymeworks for ZW25 in Gastric Cancer February 24, 2017 ZW25 is an antibody intended as a treatment for patients with a tumor expressing HER2. Read More
FDA Approves Duchenne Muscular Dystrophy Treatment for Children February 16, 2017 The FDA fast-tracked the application and prioritized its review as an orphan drug. Read More
Amgen Secures FDA Approval for Parsabiv to Treat Secondary Hyperparathyroidism February 15, 2017 The approval was based on two placebo-controlled Phase III studies. Read More
NICE Gives Nod to Alexion's Strensiq for Narrow Use February 15, 2017 A standard course of treatment costs £366,912 (US $460,195) per patient. Read More