OR WAIT null SECS
August 16, 2016
The agency publishes guidance on the appropriate classification of co-crystal solid-state forms.
August 04, 2016
FDA approved Natco and Alvogen’s generic Tamiflu to treat and prevent influenza.
July 25, 2016
The companies filed a BLA for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis.
July 21, 2016
Generic versions of AstraZeneca’s blockbuster Crestor will hit the US market after a federal judge refused to issue a restraining order blocking the approval of rosuvastatin ANDAs.
July 18, 2016
The agency says the increasing requests for orphan drug designation has resulted in a change in FDA’s review goals.
July 11, 2016
The agency announced that it has completed the review of the GDUFA backlog one year ahead of schedule.
July 06, 2016
The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.
June 24, 2016
The agency is following up on a February 2016 inspection of the facility that found GMP violations.
The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.
The agency has suspended recommendation of Riluzole Alkem due to flawed study results.