OR WAIT null SECS
May 28, 2015
New guidance complements ICH guidelines on impurities.
May 26, 2015
Boehringer Ingelheim announces FDA approval of Stiolto Respimat inhaler for the treatment of COPD.
May 15, 2015
Raplixa fibrin sealant, the first approved spray-dried biologic, is a hemostatic agent that helps control bleeding from small blood vessels during surgery.
May 13, 2015
FDA concludes Orkambi demonstrates a clinical benefit over placebo, but questions the magnitude of the improvement.
May 04, 2015
FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.
April 28, 2015
FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.
April 24, 2015
The agency has recommended granting marketing authorization for Opdivo.
April 21, 2015
The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.
April 20, 2015
The European Medicines Agency releases findings from marketing authorization application analysis.
April 15, 2015
The document serves as guidance for the pharmaceutical industry in data integrity issues and complements existing EU GMP relating to APIs and dosage forms.