Human Drugs
EMA Recommends Suspending Generics Tested by Synchron
A European Medicines Agency committee says authorization of several generic medicines should be suspended because of questions about data submitted fo...
Human Drugs
FDA Denies Tyvaso DPI Petition
FDA denies a petition asking for restrictive agency actions on an NDA for Tyvaso.
Medical Devices
CorneaGen Recalls 1 Lot of Scleral Patch Grafts
FDA provides information on a CorneaGen recall of one lot of scleral patch grafts.
Medical Devices
NeuroMetrix De Novo Authorization for Fibromyalgia
FDA grants NeuroMetrix a de novo authorization to market its Quell neuromodulation device as an aid for reducing fibromyalgia symptoms in adults with ...
Medical Devices
Warning on Genetic Prenatal Screening Tests
FDA issues a warning about the risks of false results with genetic non-invasive prenatal screening tests.
Human Drugs
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 5/20/2022.
Human Drugs
Product Approval Summaries
FDA Webview posts product approval summaries for the week ending 5/20/2021.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Bill Would Whittle Down Biologic Exclusivity
Congresswoman Jan Schakowsky (D-IL) and congressman Bruce Westerman (R-AR) reintroduce the bipartisan Price Relief, Innovation, and Competition for Es...
Human Drugs
Partial Clinical Hold on Leukemia Therapy
FDA issues a partial clinical hold on a Foghorn Therapeutics Phase 1 dose escalation study of FHD-286 in relapsed or refractory acute myelogenous leuk...
