FDA Delays Decision on Novo Nordisk’s Diabetes Candidate IDegLira September 12, 2016 The FDA expects to decide whether to grant Novo Nordisk’s candidate an approval in December. Read More
International Single-Audit Program on Track for 2019 September 9, 2016 MDSAP was devised to leverage regulatory resources into a single audit program. Read More
Clinton Reveals Plan to Hold Drugmakers Responsible for Price Surges September 9, 2016 The proposal calls for drugmakers behind unwarranted price hikes to pay fines. Read More
Safety Label Updates to Be Presented Sooner After FDA Office Change September 8, 2016 The Office of the Commissioner’s MedWatch Program will no longer oversee the safety label change program. Read More
Theranos Withdraws Zika Application September 7, 2016 The FDA found irregularities in protocols for the trials conducted in the Dominican Republic. Read More
Amgen’s Phase III Prolia Study Checks off All Endpoints at 12 Months September 7, 2016 The data showed that Prolia treatment led to significantly greater gains in bone mineral density. Read More
FDA Pursues Input as it Reviews Off-Label Communication Rules September 6, 2016 The FDA wants to know if information from manufacturers is more informative than off-label information. Read More
Unsafe Conditions at Vitalife, Website Claims Draw FDA Warning September 6, 2016 An inspection last year by the FDA revealed violations of the FDA’s cGMP. Read More
FDA Gives Green Light to Medtronic’s Enlite Continuous Glucose Sensor September 2, 2016 The iPro2 professional system is designed to track glucose levels every 5 minutes. Read More
Novartis’ Siponimod Achieves Phase III Endpoint in MS Trial September 2, 2016 Siponimod is a selective modulator of specific types of the sphingosine-1-phosphate receptor. Read More
Theranos Withdraws FDA Emergency Clearance Request for Zika Test September 1, 2016 The company is voluntarily withdrawing its application for emergency clearance. Read More
State Court Permitted to Hear Out-of-State Plavix Suits, California High Court Says September 1, 2016 Separate trials for each complaint would lead to duplicate efforts. Read More