FDA Related News

Human Drugs

FDA Accepts Re-filed NDA for Acromegaly Drug

FDA accepts for review a Chiasma NDA resubmission for Mycapssa (octreotide) capsules for the maintenance treatment of adults with acromegaly.

Human Drugs

sNDA for Lynparza Accepted for Review

FDA accepts for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with bevacizumab for the maintenance treatment ...

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 1/10/2020.

Human Drugs

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Federal Register

Meeting on Asbestos in Talc and Cosmetic Products

Federal Register notice: FDA announces a 2/4 public meeting entitled Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc.

Biologics

Meissa Gains Fast Track for RSV Infection Vaccine

FDA grants Meissa Vaccines a fast track designation for MV-012-968, a vaccine for protection against respiratory syncytial virus infection.

Medical Devices

Reflow Medical Breakthrough for Stent System

FDA grants Reflow Medical a breakthrough device designation for the Temporary Spur Stent System, a novel retrievable stent technology intended for tre...

Medical Devices

MicroVention Flow Diverter OKd for Brain Aneurysm

FDA approves a MicroVention PMA for the FRED (Flow Re-Direction Endoluminal Device) device for treating brain aneurysms.

Petition Seeks to Stop FDA Enforcement on PGx Info

The Coalition to Preserve Access to Pharmacogenomics Information petitions FDA urging it to stop enforcement actions against genetic tests that claim ...

Human Drugs

Alnylam Rolling NDA for Lumasiran

Alnylam Pharmaceuticals begins a rolling submission of its NDA for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for trea...