FDA

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 (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…

Synopsis: Dr. Reddy’s Laboratories Ltd. on Monday introduced that the Drugs Controller General of India (DCGI) has granted approval to the single-shot…

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

Summary : The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates…

Summary : Amgen has posted a 3% rise in total 2021 fourth-quarter revenues to $6.8 billion and a 2% increase in total revenue for the year…

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

Summary : FDA approves Enjaymo™ (sutimlimab-jome), first treatment for use in patients with cold agglutinin disease Enjaymo is the only approved treatment…