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FDA Approves SetPoint Medical Arthritis Device

[ Price : $8.95]

FDA approves SetPoint Medicals SetPoint System, a novel neurostimulation device to treat some rheumatoid arthritis patients.

Makary Blames NIH for Covid Virus

[ Price : $8.95]

FDA commissioner Martin Makary pushes the idea that the National Institutes of Health funded the Wuhan, China, lab from which the ...

15 Observations in Jubilant HollisterStier FDA-483

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FDA has released the form FDA-483 issued with 15 observations from an inspection at the Jubilant HollisterStier drug manufacturing...

Cardiosense Wearable Cleared as Heart Function Monitor

[ Price : $8.95]

FDA clears a Cardiosense 510(k) for its CardioTag device, a wearable device capable of simultaneously capturing electrocardiogram,...

MDUFA Small Business Qualification Guide

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FDA publishes a guidance explaining the process it uses to determine and qualify a MDUFA small business.

Vivace Mesothelioma Drug Gets Orphan Status

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FDA grants Vivace Therapeutics an orphan drug designation for VT3989 and its use in treating mesothelioma.

House Dems Hit FDA, HHS Over Vaccines

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Top House Democrats on the Energy and Commerce Committee raise alarm over what they describe as a coordinated effort by the Trump ...

FDA Lays Out Unapproved GLP-1 Drug Concerns

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FDA issues an online statement summarizing all its concerns with unapproved versions of GLP-1 weight loss drugs being marketed to ...

AbbVie Seeks OK for All-Oral Leukemia Regimen

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AbbVie files a supplemental NDA seeking approval for a new, fixed-duration, all-oral combination regimen of Venclexta (venetoclax)...

FDA Ends Arthritis Advisory Committee

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FDA says its Arthritis Advisory Committee is no longer worth the effort and expense needed to maintain it, and it has been termina...