FDA Expands Kalydeco Approval in Cystic Fibrosis Using Lab Data May 19, 2017 The agency expanded the indication from 10 mutations to 33. Read More
France Temporarily Halts AB Science’s Clinical Trials May 18, 2017 The regulatory agency called for the suspension of trials until an external audit shows the company is compliant. Read More
Sangamo Receives FDA Fast Track Designation for Hemophilia A Gene Therapy May 18, 2017 SB-525 has already received an orphan drug designation from the FDA. Read More
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