fbpx
May 26, 2021

Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19

For Immediate Release: May 26, 2021 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab […]
May 26, 2021

Drug Trials Snapshots: YUPELRI

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
May 26, 2021

Remarks by Acting Commissioner Woodcock to the Association for Accessible Medicines 2021Access! Conference – 05/26/2021

Speech by Janet Woodcock, M.D. Acting Commissioner of Food and Drugs – Food and Drug Administration It is a pleasure to join you for this year’s […]
May 26, 2021

Drug Trials Snapshots: POLIVY

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
May 26, 2021

Drug Trials Snapshots: MOTEGRITY

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
May 26, 2021

Drug Trials Snapshot: EVENITY

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
May 26, 2021

Drug Interactions & Labeling

March 2021 Update: The FDA announces new regulatory guidance on assessing pH-dependent drug interactions Preventing and Mitigating Drug Interactions Overview Patients frequently use more than one […]
May 26, 2021

Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication – Due to Risk of Serious Liver Injury, FDA Restricts Use of Ocaliva in Primary Biliary Cholangitis Patients with Advanced Cirrhosis

[Posted 05/26/2021]  AUDIENCE: Patient, Health Professional, Pharmacy    ISSUE: The FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis […]
May 26, 2021

Drug Development and Drug Interactions: Advisory Committee Meetings

2013 2012  no ACPS-CP meeting 2011 2010 2009  no ACPS-CP meeting 2008 2007  no ACPS-CP meeting 2006 2005 Evidence and Process for Translation of Pharmacogenetic Information […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0