FDA Related News

Human Drugs

Enhertu Approval Broadens Breast Cancer Use

FDA approves AstraZeneca and Daiichi Sankyos Enhertu (trastuzumab deruxtecan) for treating adult patients with unresectable or metastatic hormone rece...

Human Drugs

No Informed Consent at Trial Site: FDA

FDA warns the Miami Dade Medical Research Institute and Dr. Americo Padilla about failing to obtain proper informed consent for pediatric patients in ...

Biologics

2 Firms Illegally Selling Biologics: FDA

FDA warns New York, NY-based Evolutionary Biologics and Chatsworth, CA-based Chara Biologics about illegally manufacturing and distributing unapproved...

Human Drugs

FDA Priority Review for New Merck Welireg Indication

FDA sets 5/25 for its decision on a new indication for Mercks Welireg to treat patients with advanced pheochromocytoma and paraganglioma.

Medical Devices

AI Optics Handheld Retinal Imager Cleared

FDA clears an AI Optics 510(k) for its Sentinel Camera, a handheld retinal imaging device for capturing images of the human eye.

TerSera Wants Prialt ANDA Conditions

TerSera petitions FDA to require any ANDA referencing Prialt to conduct compatibility testing with the Medtronic pump that is specified in Prialts lab...

FDA General

RFK Jr.s Cousin Trashes Him on Eve of Hearing

Robert F. Kennedy Jr.s cousin, Caroline Kennedy, sends a scathing letter about his background to U.S. senators on the eve of a confirmation hearing to...

Human Drugs

Additional Ozempic Indication Approved

FDA approves a new indication for Novo Nordisks Ozempic to reduce the risk of worsening kidney disease and cardiovascular death in adults with Type 2 ...

Medical Devices

Alzheimers Assay Gets Breakthrough Designation

FDA grants Beckman Coulter Diagnostics a breakthrough device designation for its Access p‑Tau217/β-Amyloid 1-42 plasma ratio assay to help ...

Medical Devices

Stroke Device Cleared for Larger Catheters

FDA clears an Imperative Care 510(k) for its Zoom System, a stroke thrombectomy system with .088-inch catheters.