Human Drugs
Spectrum NDA Accepted for HER2 Lung Cancer
FDA accepts for review a Spectrum Pharmaceuticals NDA for poziotinib and its use in treating patients with previously treated locally advanced or meta...
Human Drugs
OGD Approved 100 Competitive ANDAs in 2021
CDERs Office of Generic Drugs says it approved 100-designated Competitive Generic Therapy ANDAs in 2021 for products recognized as lacking generic com...
Human Drugs
ProQR Trial in Eye Disease Fails
A pivotal Phase 2-3 trial (Illuminate) evaluating ProQR Therapeutics sepofarsen for treating genetic eye disease CEP290-mediated Leber congenital amau...
Medical Devices
Motus GI Gets New Colonoscopy Device Cleared
FDA clears a Motus GI Holdings 510(k) for the Pure-Vu EVS System for colonoscopies.
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 2/11/2022.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 2/11/2021.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Spore Test Strip Put Into Class 2
Federal Register notice: FDA classifies the spore test strip into medical device Class 2 (special controls).
Federal Register
Class 2 for Predictive Cardiovascular Indicator
Federal Register notice: FDA classifies the adjunctive predictive cardiovascular indicator into medical device Class 2 (special controls).
Medical Devices
Senseonics Continuous Glucose Monitor Approved
FDA approves a Senseonics Holdings next-generation Eversense E3 continuous glucose monitoring system and its use for up to six months.
