FDA Related News

Medical Devices

Abbott Recalls HeartMate Power Units

Abbott recalls its HeartMate Mobile Power Unit to remove the component due to instances where the device experiences a sudden power loss.

Human Drugs

Staff Cuts Lead to Drug Data Gaps: Sources

Axios reports that key FDA databases that are relied on by healthcare professionals are not being fully updated due to staff shortages resulting from ...

Human Drugs

FDA OKs Akesos Nasopharyngeal Cancer Therapy

FDA approves an Akeso Biopharma BLA for penpulimab-kcqx, indicated for adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.

ASCO Reaches Out to FDA, NIH, CMS

The Association for Clinical Oncology tells the new leaders of FDA, NIH, and CMS it looks forward to working with them on behalf of cancer research an...

Human Drugs

Cobenfy Effective as Schizophrenia Adjunct: Trial

Bristol Myers Squib says its Cobenfy showed positive results in the Phase 3 ARISE trial as an adjunctive therapy to atypical antipsychotics for patien...

Human Drugs

Update Drug Labels with Obesity Info: Pitts

Former FDA associate commissioner Peter Pitts calls on the agency to revise drug labels with obesity safety and effectiveness information.

Human Drugs

Lilly Sues 4 More Weight-Loss Drug Compounders

Lilly sues four additional drug compounders for illegally selling copies of its weight loss and diabetes drugs.

Medical Devices

Alert Issued on Conavis Novasight Catheters

The catheter is part of a system intended for intravascular imaging of coronary arteries.

Biologics

FDA Seeks Post-Marketing Commitment from Novavax

Novavax says its Covid-19 vaccine BLA is being held up while FDA seeks to conclude a post-marketing commitment from the company.

Medical Devices

CereVasc Gains Breakthrough Status for eShunt

FDA grants CereVasc a breakthrough device designation for its investigational eShunt System and its use in treating communicating hydrocephalus.