FDA confirms the survival rate of Abiomeds Impella RP System that was required to undergo a post-approval study after being approved in 2017.
Pfizer and BioNTech file an application seeking an emergency use authorization for their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine as the th...
Federal Register notice: FDA makes available a draft guidance entitled Statistical Approaches to Establishing Bioequivalence.
Novartis says it will seek FDA approval for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan), for slowing disease progression in c...
FDA posts a final guidance entitled E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical T...
FDA accepts for review a Protalix BioTherapeutics and Chiesi BLA resubmission for PRX102 (pegunigalsidase alfa) for treating adult patients with Fabry...
Federal Register notice: FDA makes available a revised draft guidance entitled ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Ge...
FDA posts a draft guidance entitled ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions.
