First Patients Treated With CorMatrix Tyke June 22, 2016 The product gained FDA clearance last February. Read More
Janssen Files Lawsuit Against GE Subsidiary Over Remicade Biosimilar June 22, 2016 The GE unit is being sued over the use of cell cultures to grow a biosimilar of the drug. Read More
Lombard Medical Gains CE Mark Approval June 21, 2016 The company expects a full launch later in the year. Read More
New Bill Aims to Combat Price Hikes June 21, 2016 A bipartisan group of senators introduced the bill. Read More
Cerus, BARDA Enter Funding Agreement June 20, 2016 Under the five-year agreement, BARDA will initially provide $30.75 million in funding. Read More
FDA Cites RC Outsourcing in 483 for Testing Slips, Door Gaps June 20, 2016 Inspectors discovered that the company does not test each batch of endotoxin injectable. Read More
Sterile Compounder Lands Form 483 Over Sterility Issues June 17, 2016 The agency cited the drugmaker for sterility and record-keeping issues. Read More
Miraca Life Sciences Launches InformTx June 16, 2016 A test requires a five to seven milliliter peripheral blood sample. Read More
Valeant Coughs Up $54 Million to Settle Kickback, Fraud Allegations June 16, 2016 Payment will settle allegations against subsidiary Salix Pharmaceuticals. Read More
Meridian Bioscience’s Illumigene Mycoplasma Test Nabs FDA Clearance June 15, 2016 The test uses throat swabs to detect infection on the first day of symptoms. Read More
Report: Quality Control and Assurance Lapses Most Frequent Issues Among Chinese Drugmakers June 15, 2016 20 percent of the 3,045 deficiencies were linked to quality control and assurance. Read More