FDA
The vaccine, Vaxelis, was approved to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenza type b.
As 2018 comes to a close, analysts, journalists, investors and industry-watchers are studying their crystal balls to see what trends to watch in the upcoming year. Here are 7 trends most likely to be hitting the news cycle.
After a delay in review, the FDA approved Acorda’s Inbrija for the intermittent treatment of OFF episodes of Parkinson’s.
Alexion Pharmaceuticals and Stemline Therapeutics both secured FDA approval for their drugs.
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.
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.
AC5™ provides a new option for the treatment of topical wounds
Intuitive and Discreet Device Provides Sacral Neuromodulation Therapy for Overactive Bladder and Bowel Incontinence
The U.S. Food and Drug Administration approved another biosimilar. On Friday, the regulatory agency approved Herzuma, a biosimilar to Genentech’s Herceptin developed by South Korea-based Celltrion, Inc. and Israel-based Teva Pharmaceuticals.
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