Food and Drug Administration (FDA)
NEWS
Bavarian Nordic A/S today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for the liquid-frozen version of the MVA-BN®for active immunization against smallpox in adults age 18 years and older.
Companies closed out the year with a number of appointments and hires to strengthen their leadership teams, including changes at the FDA, Melinta, CLSA, Virion, and more.
According to the U.S. Centers for Disease Control and Prevention (CDC), 12 people in three states were hospitalized for infections caused by bacterial contamination of stem cell products.
Using a calculation, ICER believes the Novartis gene therapy for Spinal Muscular Atrophy will be more cost effective than Biogen’s Spinraza.
The FDA has been looking for ways to increase access to naloxone, an opioid overdose reversal drug, and the new guidelines are part of that effort.
Merck & Co. found itself with two new approvals this week. The FDA approved Lynparza (codeveloped by AstraZeneca and Merck) and also approved Merck’s Keytruda. Both of these drugs were approved for new indications.
With the holidays upon us, along with the end of 2018 and the beginning of 2019, the FDA squeezed some target action dates into the last weeks and beginning of the new year. As it turned out, these appear to be a mixed bag of extensions, resubmissions and supplemental applications, some of which are still pending while others have been approved earlier. Here’s a look.
Researchers at the University of Wisconsin-Madison have developed a battery-free, easily implantable device, about a third the size of a penny, that helped laboratory rats lose weight.
Amy Abernethy, the chief medical officer of Roche-owned Flatiron Health, has been named the Principal Deputy Commissioner of Food and Drugs at the U.S. Food and Drug Administration.
JOBS
IN THE PRESS