Under12

Summary : ALYMSYS® was developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization…

Summary : Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol…

Summary : Peter Pitts, a former FDA associate commissioner and president of the Center for Medicine in the Public Interest, discusses the…

Summary : Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the…

Summary : GC Pharma (KRX:006280) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug…

Summary : The U.S. Food and Drug Administration has accepted Mirati Therapeutics’ New Drug Application (NDA) for its candidate drug for non-small cell lung cancer (NSCLC). The…

Synopsis: The U.S. Food and Drug Administration announced it is investigating a possible death risk for TG Therapeutics’ Ukoniq (umbralisib). The drug…

Today, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine;…

KEYPOINTS FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age. Effectiveness: Immune responses of children…