CHMP Recommends 7 Drugs for Approval in the EU January 4, 2017 In addition, the CHMP recommended extensions of indication for nine more medicines. Read More
Two-Thirds of Drugs Approved in 2016 Granted Priority Review January 3, 2017 The FDA approved 22 novel drugs in 2016, down from 45 approvals the year before. Read More
Apellis Wins FDA Fast Track Designation for APL-2 in PNH January 3, 2017 The candidate is intended for those who continue to experience hemolysis and require red blood cell transfusions. Read More
EMA’s Priority Medicines Eligibility and FDA Breakthrough Therapy Designation Awarded to Juno and Celgene’s JCAR017 January 3, 2017 EMA’s CHMP granted JCAR017 access to its Priority Medicines scheme. Read More
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