Approval

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 : One of Eli Lilly’s diabetes drugs just scored another win with the U.S. Food and Drug Administration to expand its…

Summary: The U.S. Food and Drug Administration (FDA) has revised its emergency use authorization (EUA) for AstraZeneca’s Evusheld to a higher dose…

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…

Summary – -On the day the public and members of the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory…

MINUTES OF THE 436th REGISTRATION COMMITTEE MEETING HELD ON 28.01.2022 The 436th meeting of the Registration Committee (RC) was held under the…

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