QT Vascular’s Chocolate Heart Drug-coated Balloon Wins CE Mark Clearance July 11, 2016 The balloon features a “nitinol-constraining structure.” Read More
HHS Nearly Doubles Number of Patients Eligible for Opioid Rescue Drugs July 11, 2016 Physicians will be able to prescribe buprenorphine and buprenorphine combined with naloxone. Read More
HeartWare Broadens Recall for Batteries July 8, 2016 The recall extends to 18,631 units nationwide. Read More
BMS Buys Cormorant for $520M July 8, 2016 BMS will gain all outstanding shares and the rights to Cormorant’s HuMax-IL8. Read More
FDA Publishes Draft Guidance on Vulvovaginal Candidiasis Drug Development July 7, 2016 The agency suggested that these trials be randomized. Read More
Electrosurgical Device Classified as Class II July 7, 2016 Electrosurgical devices use radiofrequency energy to produce localized heating. Read More
U.S. Supreme Court to Review DNA Test Kit Patent Battle July 6, 2016 The case between Life Technologies and Promega involves genetic testing technology. Read More
Richard Pazdur Named as Head of New Oncology Center for Excellence July 6, 2016 Califf appointed Pazdur to serve as acting director of the new center. Read More
FDA, Industry Inch Closer Toward MDUFA Agreements July 5, 2016 A MDUFA counter-proposal suggests a slowly closing gap between negotiations. Read More
Chinese API Makers Land Warning Letters For Falsified Data, Improper Testing July 5, 2016 One warning letter addresses Chongqing Lummy Pharmaceutical. Read More
Medtronic Picks Up HeartWare July 1, 2016 Under the deal, Medtronic will gain all outstanding shares for $58 per share. Read More
Opdivo Lands Another Breakthrough Therapy Designation July 1, 2016 Opdivo nabbed the designation for treatment of metastatic urothelial carcinoma. Read More