FDA Related News

Medical Devices

Multiple Violations in Spectra Therapy Inspection

FDA warns Port Huron, MI-based Spectra Therapy about Quality System, Medical Device Reporting, and Unique Identifier violations in its production of a...

Human Drugs

Promising Ianalumab Data for Thrombocytopenia: Novartis

Novartis says its experimental antibody ianalumab, when combined with eltrombopag, significantly extended the time to treatment failure in patients wi...

Medical Devices

Draeger Recalls Ventilator Breathing Filters

Draeger recalls (Class 1) its SafeStar and TwinStar breathing filters due to a risk of misleading carbon dioxide readings.

Elsa Hallucinations Not A Surprise: AI Expert

AI expert Brooke Moy says FDA may have felt pressured to move too quickly to implement its Elsa internal AI tool without planning for sufficient human...

Human Drugs

Brinsupri Approved for Non-Cystic Fibrosis Bronchiectasis

FDA approves an Insmed NDA for Brinsupri (brensocatib) tablets as the first treatment for non-cystic fibrosis bronchiectasis in patients aged 12 and o...

Human Drugs

Keytruda/Padcev Study in Bladder Cancer Positive: Merck

Merck announces that the combination of Keytruda (pembrolizumab) and Pfizers Padcev (enfortumab vedotin-ejfv), given before and after surgery, signifi...

Medical Devices

Get Strategic Intelligence from Device Warnings

A MedDevice Online column says manufacturers can often avoid an FDA Warning Letter by providing an urgent and accountable full response to a form FDA-...

Biologics

FDA May Nix Pfizer EUA for Covid Jab in Young Kids

The Guardian reports that the emergency use authorization for Pfizers Covid-19 vaccine for children under five may not be renewed by FDA this fall.

Human Drugs

Hes Back: Makary Rehires Prasad as CBER Head

Vinay Prasad returns as CBER head at FDA commissioner Marty Makarys request after gaining White House approval.