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Warning Letter Issued to Meridian Bioscience

[ Price : $8.95]

FDA sends a Warning Letter to Meridian Bioscience over serious quality system violations involving blood lead testing devices manu...

FDA Warns MAST Biosurgery Over Manufacturing Violations

[ Price : $8.95]

FDA issues MAST Biosurgery a Warning Letter after an August inspection cited serious manufacturing quality and safety reporting vi...

Drug Companies Using AI to Speed Submissions

[ Price : $8.95]

Reuters reports that several drug companies say they are using artificial intelligence tools to speed up some of the time-intensiv...

Scancell Advancing iSCIB1+ Into Phase 3 Melanoma Trial

[ Price : $8.95]

FDA approves a Scancell Holdings IND to begin a registrational Phase 3 trial of iSCIB1+ in patients with advanced melanoma.

Former CytoDyn CEO Sentenced to Prison

[ Price : $8.95]

A federal judge sentences former CytoDyn chief executive Nader Pourhassan to 30 months in prison for misleading investors about th...

FDA Cites Pine Pharma Over Sterility, Quality Control

[ Price : $8.95]

FDA cites Pine Pharmaceuticals for multiple quality and sterility violations following a 10-day inspection of the companys drug ou...

Plausible Mechanism Drug Pathway Raises Process Concerns

[ Price : $8.95]

A Health Affairs analysis on FDAs new pathway allowing drug approvals based on a plausible mechanism of action warns that the appr...

Sarepta Reports Positive Data on Duchenne Gene Therapy

[ Price : $8.95]

Sarepta Therapeutics announces that its gene therapy Elevidys significantly slowed disease progression over three years in ambulat...

Advocacy Push Precedes FDA Meeting on Stalled Gene Therapy

[ Price : $8.95]

AMT-130 is a gene therapy designed to lower levels of the mutant huntingtin protein believed to drive Huntingtons disease progress...

Symposium on Clinical Trials, Bioequivalence and Pharmacovigilance

[ Price : $8.95]

U.S., U.K. and Canadian drug regulators announce a joint international symposium to discuss evolving regulatory expectations for c...