Imara Receives FDA’s Rare Pediatric Disease Designation for IMR-687 for Treatment of Sickle Cell Disease May 17, 2017 Imara is conducting a Phase 1a clinical study in healthy volunteers. Read More
FDA Approves Merck’s Keytruda for First-Line NSCLC May 17, 2017 The addition of Keytruda to a regimen of carboplatin and pemextred nearly doubled the objective response rate. Read More
MHRA Grants Early Access to AbbVie’s Hepatitis C Combo Treatment May 16, 2017 The combination is currently undergoing expedited review at the EMA for all genotypes. Read More
Merck and Pfizer’s Bavencio Collaboration Nabs FDA Approval in Bladder Cancer May 16, 2017 Bavencio was previously granted accelerated approval. Read More
April Sees 66 ANDA Approvals and 112 CRLs May 12, 2017 The agency also issued 112 complete response letters, down from 190. Read More
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