FDA Related News

FDA Enforcement Year in Review

A Ropes & Gray year-end review examines significant changes in FDA and Justice Department enforcement actions pertaining to regulated industries and s...

Human Drugs

FDA Lifts Clinical Hold on Intellias Phase 3 Trial

FDA lifts a clinical hold on Intellia Therapeutics MAGNITUDE-2 Phase 3 trial evaluating nexiguran ziclumeran for patients with hereditary transthyreti...

Medical Devices

Warning Letter Issued to Meridian Bioscience

FDA sends a Warning Letter to Meridian Bioscience over serious quality system violations involving blood lead testing devices manufactured by its subs...

Medical Devices

FDA Warns MAST Biosurgery Over Manufacturing Violations

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

Biologics

Scancell Advancing iSCIB1+ Into Phase 3 Melanoma Trial

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

Human Drugs

Plausible Mechanism Drug Pathway Raises Process Concerns

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

Biologics

Sarepta Reports Positive Data on Duchenne Gene Therapy

Sarepta Therapeutics announces that its gene therapy Elevidys significantly slowed disease progression over three years in ambulatory patients with Du...

Biologics

Advocacy Push Precedes FDA Meeting on Stalled Gene Therapy

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

FDA General

Symposium on Clinical Trials, Bioequivalence and Pharmacovigilance

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

Human Drugs

Former CytoDyn CEO Sentenced to Prison

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