FDA Related News

Human Drugs

Caris Companion Diagnostic for Cancer Approved

FDA approves Caris Life Sciences MI Cancer Seek and its use as a companion diagnostic to identify cancer patients for treatment with several targeted ...

Medical Devices

ACLA Views on PCCP Draft Guidance

The American Clinical Laboratory Association submits comments to an FDA draft guidance on medical device predetermined change control plans.

FDA General

RFK Jr. Says Some FDA Departments Have to Go

In an interview the day after the election, president-elect Donald Trumps top health advisor Robert F. Kennedy Jr. says there are some FDA departments...

Medical Devices

Breakthrough Designation for SeaStar Dialysis Device

FDA grants a fourth breakthrough device designation for SeaStar Medicals Selective Cytopheretic Device.

Human Drugs

Objectionable Conditions at Hospital IRB

FDA warns the Kittanning, PA-based Armstrong County Memorial Hospital IRB about objectionable conditions identified in a Bioresearch Monitoring Progra...

FDA Cant Regulate AI on its Own: Califf

FDA commissioner Robert Califf says collaboration with external stakeholders is needed to adequately monitor and regulate artificial intelligence.

Human Drugs

Acadia Unloads Priority Voucher for $150 Million

Acadia Pharmaceuticals sells its Rare Pediatric Disease Priority Review Voucher for $150 million.

Medical Devices

FDA OKs Envoy Medical Cochlear Implant Study

FDA approves an Envoy Medical IDE for its pivotal study of the Acclaim Fully Implanted Cochlear Implant.

Human Drugs

Extended Review for Organons Vtama sNDA

FDA extends by three months its review of an Organon supplemental NDA for Vtama (tapinarof) cream and its use for treating atopic dermatitis.

Human Drugs

CGMP Issues at Chinas Shandong Boyuan

FDA issues an untitled letter to Chinas Shandong Boyuan Pharmaceutical Co. about CGMP deviations in its manufacturing of active pharmaceutical ingredi...