WHO to Begin Prequalifying Biosimilars for UN Use May 11, 2017 The WHO also plans to advocate for lower prices for all biologic drugs. Read More
Axsome Therapeutics Receives FDA Fast Track Designation for AXS-05 May 11, 2017 The drug is a combination of bupropion and dextromethorphan. Read More
XyloCor Therapeutics Wins Fast Track Designation For XC001 May 10, 2017 XC001 is a gene therapy that promotes angiogenesis. Read More
FDA Accepts Pfizer’s Applications for Xeljanz in Psoriatic Arthritis May 10, 2017 The sNDA submissions are based on data from two Phase III trials and a long-term extension study. Read More
Sanofi Genzyme Gains Health Canada Approval for Cerdelga May 9, 2017 Gaucher disease is a genetic metabolic condition caused by deficient activity of the enzyme glucocerebrosidase. Read More
AstraZeneca’s Imfinzi Wins FDA Accelerated Approval for Previously Treated Patients with Advanced Bladder Cancer May 9, 2017 Imfinzi is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma. Read More
Altor BioScience Gains FDA Fast Track Designation for Bladder Cancer Drug May 8, 2017 ALT-803 is currently being evaluated in a Phase Ib/II clinical trial. Read More
FDA Requests Long-Term Safety Info for Intra-Cellular’s Schizophrenia Drug May 8, 2017 The company revealed positive topline results from a Phase III lumateperone trial last September. Read More
April Sees 66 ANDA Approvals and 112 CRLs May 5, 2017 The FDA received 75 ANDAs in April, a steep drop from the 197 received in the previous month. Read More
European Commission Approves Bristol-Myers Squibb’s Opdivo May 5, 2017 Opdivo uses the body’s immune system to help restore anti-tumor immune response. Read More
FDA Gives Nod to Radius Health’s Osteoporosis Drug Tymlos May 5, 2017 The drug has also been shown to increase bone mineral density. Read More
FDA Approves Combination Treatment for Acute Myeloid Leukemia May 4, 2017 The drug is approved for use with a companion diagnostic. Read More