FDA Grants Priority Review to Tesaro’s Niraparib December 28, 2016 Its PDUFA date is set for June 2017. Read More
Pfizer Announces FDA Will No Longer Require Warning Label for Its Chantix Medication December 23, 2016 The FDA made its decision based on results from an 8,144-subject study. Read More
NICE Rebuffs Reimbursement of Takeda’s Hodgkin’s Lymphoma Drug Adcetris December 22, 2016 Takeda submitted new data and analyses to NICE. Read More
FDA Grants Priority Review to AstraZeneca’s Durvalumab December 20, 2016 The application is based on the results of a Phase I/II trial. Read More
EC Grants Conditional Marketing Approval for Venclyxto in CLL December 20, 2016 The approval includes patients that are unsuitable for or have failed previous pathway inhibitor treatments. Read More
Biohaven Achieves Orphan Drug Designation for ALS Drug Candidate December 19, 2016 BHV-0223 is administered under the tongue as a dissolving tablet. Read More
Pediapharm Nabs Health Canada Approval for Bacterial Ear Infection Treatment December 19, 2016 The approval was based on two multicenter, randomized, double-blind Phase III trials. Read More
GSK Seeks EU Approval for Pulmonary Disease Triple Combo T December 12, 2016 The submission is based on results from a Phase 3 trial of the triple combo therapy. Read More
FDA Extends Diabetic Drug Jardiance’s Label to Include Protection from Cardiovascular Death December 9, 2016 Jardiance was shown to reduce the risk of cardiovascular death. Read More
FDA Accepts Emmaus' New Drug Application for Sickle Cell Disease December 8, 2016 The clinical data indicated a reduction in the frequency of sickle cell crises and hospitalizations. Read More
Mylan and Biocon Submit Proposed Biosimilar Trastuzumab to FDA December 8, 2016 Trastuzumab is indicated to treat certain HER2-positive breast and gastric cancers. Read More
EC Approves Parsabiv for Treatment of Secondary Hyperparathyroidism December 6, 2016 This first time approval is based on three Phase III studies. Read More