drug approval

Summary : –Japanese pharma Eisai has backed away from its 50:50 profit-sharing arrangement with Biogen for troubled Alzheimer’s therapy Aduhelm, handing over…

Summary The U.S. Centers for Medicare & Medicaid Services (CMS) just completed the open comment period for their draft national coverage decision…

Summary – The House Energy and Commerce Committee’s health panel met to discuss renewing user fee agreements used to fund the U.S.…

Synopsis -Ahead of its New Year’s Day decision deadline at the FDA, Xeris Biopharma has snagged an approval for Recorlev, a drug…

Synopsis: After a special meeting, the Japanese drug reviewers ruled that existing data didn’t support an approval and are therefore seeking additional…