FDA lifts a clinical hold on Rocket Pharmaceuticals pivotal Phase 2 trial of RP-A501, an investigational gene therapy for Danon disease.
Experts share varying opinions with Clinical Trials Arena on the impact of an FDA rule barring biotech companies from sending cells from U.S. patients...
Some 750 current and former HHSers call on secretary Robert F. Kennedy, Jr., to protect them and the rest of his staff from attacks by ending his inac...
Updated medical device breakthrough device designation metrics show 1,176 approvals since 2015 and 160 marketing authorizations.
FDA suggests ways CytoSorbents can proceed with its de novo application for DrugSorb-ATR.
Wiley Rein petitions FDA to take seven specific actions to address public health risks associated with compounded semaglutide drug products.
FDA extends until the fourth quarter the review of two Regeneron Pharmaceuticals regulatory submissions for Eylea HD (aflibercept) injection 8 mg regu...
B. Braun Medical recalls (Class 1) one lot each of its Lactated Ringers Injection USP 1,000 mL and 0.9% sodium chloride injection USP 1,000 mL due to...
