Merck Zostavax, Rotateq To Receive Committee Reviews In December
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s Vaccines & Related Biological Products Advisory Committee will meet Dec. 14-15 to discuss the herpes zoster and rotavirus vaccines.
You may also be interested in...
RotaShield Return? Biovirx Plans Global Reintroduction Of Vaccine
Biovirx obtained a global license from NIH; the firm will seek a partner for the U.S. and Europe. Wyeth withdrew the rotavirus vaccine in July 1999 due to an increased risk of intussusception in vaccinated infants.
FDA Antihypertensive Draft Class Labeling To Be Reviewed By Cardio-Renal Committee
FDA’s proposal for relabeling of antihypertensive agents is based on prior recommendations by the committee that information on cardiovascular outcomes related to blood pressure lowering be included as class labeling.
Bristol Sprycel For Gleevec-Resistant Leukemia To Get Committee Review At June ASCO Meeting
FDA’s Oncologic Drugs Advisory Committee will meet in Atlanta to review Bristol’s multi-targeted kinase inhibitor dasatinib for two leukemia indications.