FDA Related News

Human Drugs

FDA Soliciting CNPV Pilot Interest

FDA solicits statements of interest in being one of no more than five drug and biologic developers to participate in the initial cohort for the Commis...

Human Drugs

Few ODAC Advisory Committee Questions Difficult: Study

University researchers say they found relatively few instances in which Oncology Drugs Advisory Committee members reported difficulty in voting on a q...

Human Drugs

FDA SSDC White Paper Out

CDER issues a white paper tracing the history of selective safety data collection (SSDC) and plans for the future.

Biologics

FDA Extends Review of GSK Multiple Myeloma BLA

FDA extends by three months its review of a GSK BLA for Blenrep (belantamab mafodotin) combinations for treating patients with relapsed or refractory ...

Human Drugs

Positive Trial Data on Sleep Apnea Drug

Apnimed announces positive topline results from its second pivotal Phase 3 trial of AD109 (aroxybutynin and atomoxetine), a once-daily oral pill for t...

FDAs Elsa Hallucinates Confidently: Report

Gizmodo reports that FDA employees who have used Elsa told CNN the AI tool makes up reports and hallucinates confidently.

Medical Devices

Baxter Recalls Mobile Lift Component

Baxter Healthcare recalls (Class 1) a mobile lift component used in several patient lift devices due to the risk of improper attachment.

FDA: Multiple Violations at O3UV

FDA warns Grand Ledge, MI-based O3UV about multiple CGMP violations in its illegal production of autohemotherapy devices.

Human Drugs

CGMP Violations at Glenmark Unit

FDA warns Indias Glenmark Pharmaceuticals about CGMP violations in the production of finished drugs at one of its manufacturing facilities.

Biologics

FDA Rejects Replimune BLA for Melanoma Therapy

FDA rejects a Replimune priority-reviewed BLA for its melanoma therapy RP1 (vusolimogene oderparepvec).