NICE Endorses Intercept’s Ocaliva as Treatment for Chronic Liver Disease March 13, 2017 Ocaliva is an option for patients that do not fully respond to or are intolerant to the current treatment. Read More
FDA Approves Prolonged Shelf Life and Storage Temperature for Orfadin March 13, 2017 Orfadin is a synthetic reversible inhibitor indicated for use as an adjunct to dietary restrictions. Read More
FDA Grants Orphan Drug Designation to Prometic’s PBI-4050 for Alström Syndrome March 10, 2017 The company is investigating the effects of PBI-4050 on multiple organs. Read More
NICE Backs Expanded Use of Merck's Erbitux as Initial Treatment for Colorectal Cancer March 10, 2017 The endorsement is based on clinical evidence that showed Erbitux improves patient survival. Read More
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