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Makary Blames NIH for Covid Virus

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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

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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...

Speed Access to Drugs and Cut Drug Use: Makary

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FDA commissioner Martin Makary says he wants to find ways to get drugs to consumers faster, but also find ways to reduce the need ...