Announced Exclusive Licensing Agreement with Viatris for Sotagliflozin in all Markets Outside of the U.S. and Europe Completed ZYNQUISTA™ FDA Advisory Committee Meeting; PDUFA Goal Date December 20, ...
Despite advances in pharmacovigilance, numerous deficiencies have been identified; postmarketing surveillance remains the weakest link in the regulatory process. Regulatory authorities have tended ...
Announced Exclusive Licensing Agreement with Viatris for Sotagliflozin in all Markets Outside of the U.S. and Europe Completed ZYNQUISTA FDA Advisory Committee Meeting; PDUFA Goal Date December 20, 20 ...
The FDA has updated the labels for all GLP-1 receptor agonists, including popular medications Ozempic, Wegovy, Saxenda and Mounjaro, to include a new warning about the risk of pulmonary aspiration ...