FDA Related News

Human Drugs

FDA Lifts Partial Hold on Curis Leukemia Trial

FDA lifts a partial clinical hold on the Curis Phase 1/2 trial of emavusertib in the TakeAim Leukemia study.

DTC Guidance May Signal Enforcement Shift: Attorneys

Three Hogan Lovells attorneys say a recently finalized FDA guidance on DTC drug promotion may signal an increase in promotion enforcement.

Medical Devices

Illumina Cybersecurity Vulnerability is Class 2: FDA

DA says a cybersecurity vulnerability in several Illumina DNA sequencing devices is Class 2.

Human Drugs

Ipsen Planning FDA Elifibranor Application

Ipsen says it plans to file a regulatory application with FDA for its elafibranor to treat adults with primary biliary cholangitis.

Human Drugs

FDA Full Approval for Eisais Leqembi

FDA converts Eisais Alzheimers drug Leqembi from accelerated to traditional approval based on the results of a confirmatory trial that demonstrated it...

Human Drugs

Guidance Explains FDA 503B Wholesaling Ban

Reed Smith attorneys analyze an FDA draft guidance on the Section 503B wholesaling prohibition.

Human Drugs

CRL for Regeneron Aflibercept BLA

FDA issues a complete response letter for a Regeneron BLA for aflibercept 8 mg, citing its review of a third-party filler inspection.

Medical Devices

FDA to Again Try to Regulate LDTs: Attorneys

Four Sidley Austin attorneys say FDA is planning to issue a notice of proposed rulemaking to assert its authority to regulate laboratory-developed tes...

Human Drugs

FDA OKs SystImmune Phase 1 Lung Cancer Study

FDA says SystImmune can start Phase 1 studies of its BL-B01D1 in some lung cancer patients.

Human Drugs

FDA Actions Follow Advisors 88% of Time: Analysis

Harvard Medical School researchers find FDA follows advisory committee recommendations 88% of the time, but is relying less on them.