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Human Drugs

FDA Nixes Hydroxychloroquine Emergency Use

FDA revokes the emergency use authorization that allowed chloroquine phosphate and hydroxychloroquine sulfate to be used to treat certain hospitalized...

Medical Devices

Canon Medical MRI Speeder Cleared

FDA clears a Canon Medical 510(k) for the compressed Speeder technology for the companys Vantage Orian 1.5T MRI system that is intended to speed up MR...

Human Drugs

Mercks Gardasil 9 Expanded Indication

FDA approves Mercks Gardasil 9 (human papillomavirus (HPV) 9-valent vaccine, recombinant) for preventing oropharyngeal and other head and neck cancers...

Medical Devices

Q&A Page For Device Adverse Event Reports

FDA posts a question and answer Web page to address adverse event reporting for medical devices distributed under Emergency Use Authorizations.

Human Drugs

Safety Alert on Remdesivir Interactions

A new FDA safety alert warns health care providers about a newly discovered potential drug interaction related to Gilead Sciences investigational anti...

Biologics

Eucyt Labs Warning Letter Over Cell Product

FDA issues a Warning Letter to Eucyt Laboratories based on an inspection 11/2019 that cited the firms cell/tissue products for not having agency appro...

Human Drugs

Lilly Begins Covid Trial of Baricitinib

Eli Lilly enrolls the first patient in a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib...

Human Drugs

3rd Complaint Filed in Generic Drug Price-Fixing Case

Some 51 states and territories file a third complaint in Connecticut federal court alleging that 26 generic drug companies conspired to fix price on s...

Medical Devices

FDA Grant to Fund Pediatric Device Challenge

An FDA grant and a philanthropic gift from Mei Xu, founder of e-commerce platform Yes She May, will fund a product development competition focused on ...

Biologics

Viela Bio BLA for Optic Rare Disease Approved

FDA approves a Viela Bio BLA for Uplizna (inebilizumab-cdon) injection for intravenous use for treating neuromyelitis optica spectrum disorder.