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March 20, 2018
The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.
The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.
March 19, 2018
The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.
March 09, 2018
The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).
March 07, 2018
The agency has approved a new HIV treatment for patients with "limited treatment options".
February 21, 2018
The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.
February 15, 2018
The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.
FDA approves Vertex's cystic fibrosis drug, Symdeko (tezacaftor/ivacaftor and ivacaftor), which is made using a continuous manufacturing process.
February 14, 2018
The agency provides information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms.
February 06, 2018
Paratek has completed submission of two new drug applications for oral and intravenous omadacycline, a new antibiotic for pneumonia and skin infections.