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April 29, 2016
The agency extends the indication of the drug in combination with bendamustine.
The agency recommends the approval of Zavicefta to treat infections caused by resistant bacteria.
April 15, 2016
FDA’s breakthrough drug initiative is more popular and successful than ever.
April 08, 2016
The FDA guidance describes information to provide to the agency when submitting a proposed proprietary name.
April 07, 2016
The campaign against opioid abuse opens door to more innovative therapies.
March 29, 2016
Cinqair is approved for patients that have a history of severe asthma attacks despite receiving their current asthma medication.
The drug is marketed by Eli Lilly in the US, and will be available at the beginning of the second quarter of 2016.
March 22, 2016
The BARDA-supported monoclonal antibody was approved both as a treatment after anthrax exposure and as an anthrax prophylactic.
March 16, 2016
CDER is now prioritizing review of generic drug products for which there is only one approved drug product on the market.
March 02, 2016
Policy makers debate strategies for promoting access to less costly medicines.