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Human Drugs

Novo Nordisk Halts 3 Hemophilia Trials Over Safety

Novo Nordisk stops two clinical trials in its concizumab Phase 3 development program and one clinical trial in the Phase 2 program due to safety issue...

Medical Devices

FDA Updates Coronavirus Test FAQs

FDA adds three questions to its FAQs on developing Covid-19 diagnostics.

Human Drugs

SGLT2 Inhibitor Safety Label Changes

FDA approves safety labeling changes for four SGLT2 inhibitors to recommend that their use be temporarily discontinued several days before planned sur...

Federal Register

FDA Gene Therapy Panel Research Update

Federal Register notice: FDA announces a 5/8 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to hear research update.

Federal Register

Guide on Slowly Progressive, Low-Prevalence Rare Diseases

Federal Register notice: FDA makes available a final guidance on drugs for slowly progressive, low-prevalence rare diseases with substrate deposition.

Federal Register

Comments Extended on Homeopathic Drug Guide

Federal Register notice: FDA extends the comment period on a draft guidance entitled Drug Products Labeled as Homeopathic.

Federal Register

Competitive Generic Therapies Guidance

Federal Register notice: FDA makes available a final guidance entitled Competitive Generic Therapies.

Coronavirus Testing Improving This Week: Gottlieb

Former FDA commissioner Scott Gottlieb says that with new approved testing coming online the U.S. will be in good shape for coronavirus testing by the...

Human Drugs

Endologix PMA OKd for Abdominal Stent Graft

FDA approves an Endologix PMA Alto Abdominal Stent Graft System (Alto) for endovascular abdominal aortic aneurysm repair.

Human Drugs

Sen. Warner Wants Drug Making Moved Back to U.S

Sen. Mark Warner (D-VA) writes HHS urging it to develop a long-term plan to move pharmaceutical manufacturing back to the U.S. to reduce reliance on f...