FDA Related News

Biologics

Takeda Withdraws BLA for Dengue Vaccine

Takeda withdraws a BLA submission for its dengue vaccine candidate, TAK-003, after an FDA discussion on aspects of data collection, which cannot be ad...

Medical Devices

FDA Clears Avatar VR Surgical Planner

FDA clears the Avatar Medical virtual reality surgical planning solution.

Human Drugs

Cipla Recalls 6 Albuterol Sulfate Aerosol Batches

FDA says Cipla has recalled six batches of albuterol sulfate inhalation aerosols due to a container defect that could lead the inhaler to not deliver ...

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Reed Smith attorneys analyze an FDA draft guidance on the Section 503B wholesaling prohibition.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