Senators Call on Industry, Public for Input on Gilead Pricing Concerns January 28, 2016 Sens. Ron Wyden and Chuck Grassley are looking for ways to reduce prescription drug prices while increasing transparency. Read More
FDA Grants Additional Clearance for Velano’s Blood Draw Device January 27, 2016 Decision covers two modifications to the product. Read More
California Medicine Company Recalls Morphine-laced Cough Syrup January 27, 2016 Morphine was found in some of the bottles. Read More
Surgical Specialties Corp. Acquires FSSB Chirurgische Nadein GMBH January 26, 2016 Deal creates one of the largest global manufacturers of needles used in medical devices. Read More
BI Must Submit Settlement Papers to FTC After Supreme Court Rejection January 26, 2016 SCOTUS rejected the company’s assertion that the documents are protected communications. Read More
Jan Medical to Use Funding for U.S., EU Regulatory Activities January 25, 2016 The $7.5 million in funding comes from Germany’s Brainlab, which also will help with ongoing clinical trials. Read More
Zogenix Scoops Up FDA Fast Track Status for ZX008 January 25, 2016 The candidate aims to treat seizures associated with Dravet syndrome, a rare form of childhood epilepsy. Read More
Ambry Unveils New Neurodevelopmental Genetic Testing January 22, 2016 Neurodevelopmental disorders affect more than 4.6 million Americans, the company says. Read More
Nivalis Therapeutics Wins Orphan Drug Status for CF Treatment January 22, 2016 N91115 is a stabilizer of the cystic fibrosis transmembrane conductance regulator protein. Read More
Pelvalon Blessed by FDA, Gains Clearance for Next-Gen Eclipse System January 21, 2016 The system contains no hormones or drugs and may be removed at any time. Read More
FDA Lacks Reliable Postmarket Data for Expedited Drugs, GAO Report Finds January 21, 2016 The watchdog agency conducted the study to provide information about the FDA’s expedited programs. Read More
Japanese Health Authorities Give Thumbs Up to AtriClip Products January 20, 2016 The approval includes the AtriClip Standard and AtriClip Pro devices. Read More