FDA Related News

Biologics

Amgen Files Repatha sBLA on CV Outcomes Data

Amgen files a supplemental BLA for Repatha (evolocumab), based on a cardiovascular outcomes study (FOURIER) which the company says showed that maximal...

Medical Devices

FDA OKs Inspires Next-gen Sleep Apnea Implant

FDA approves Inspire Medical Systems next generation Inspire 3028 implantable pulse generator for treating obstructive sleep apnea.

Groups Seek Block on Bills for Off-label Communications

Public Citizen and 12 other patient advocacy groups urge the House Energy and Commerce Committee members to reject two bills that would undermine regu...

FDA General

Gottlieb Brings On 3 Hill Staffers for Advisor Roles

FDA commissioner Scott Gottlieb brings on three former Capitol Hill staffers as part of his team of advisors.

Medical Devices

FDA Extends UDI Compliance Date for Low-Risk Devices

CDRH says it intends to extend the compliance dates for the unique device identification system requirements for low-risk medical devices (certain Cla...

Medical Devices

Abbott Recalls Absorb Vascular Scaffold

Abbott begins a Class 1 recall of its Absorb Bioresorbable Vascular Scaffold system, a temporary scaffold indicated for improving coronary luminal dia...

Human Drugs

FDA Issues Lupin 6-item Form 483 After Inspection

A just-completed FDA inspection of Lupin Ltd.s Madhya Pradesh, India manufacturing facility results in a six-observation Form 483 related to GMP devia...

Human Drugs

OncBioMune Submits Phase 2 Protocol for Prostate Cancer Vaccine

OncBioMune Pharmaceuticals submits to FDA a Phase 2 clinical trial protocol for ProscaVax, a novel therapeutic cancer vaccine for early stage prostate...

Human Drugs

FDA Clears GenePOC GBS LB Assay

FDA clears a GenePOC 510(k) for its GBS LB assay and its revogene instrument, a molecular diagnostic for identifying antepartum Group B Streptococcus ...

Medical Devices

Roche PMA Approved for Zykadia Companion Diagnostic

FDA approves a Roche PMA for its Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify anaplastic lymphoma kinase-positive non-small cell...