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15 Observations in Advanced Nutriceuticals FDA-483

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FDA releases the FDA-483 detailing 15 inspection observations from an inspection at Advanced Nutriceuticals, a sterile drug produc...

EMD Serono Comments on Cybersecurity Communications

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EMD Serono suggests ways to improve an FDA discussion paper on communicating cybersecurity vulnerabilities to patients.

Feds Discuss Pfizer Vaccine Manufacturing Issues

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Federal officials report to the media that Pfizer is experiencing some vaccine manufacturing issues.

Gilead Abandons Jyseleca for RA in the U.S.

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Gilead Sciences and Galapagos abandon the U.S. development of Jyseleca (filgotinib) for Rheumatoid Arthritis after a recent meetin...

Desert Alchemist Selling Misbranded Unapproved New Drugs: FDA

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FDA warns Desert Alchemist it is selling misbranded and unapproved new drugs through its Etsy Web site.

EUA Granted for Fully At-Home Covid Test

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FDA issues an emergency use authorization for Ellumes Covid-19 Home Test, the first over-the-counter fully at-home diagnostic test...

FDA Confirms Moderna Vaccine Efficacy Ahead of Panel Vote

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FDA advisory committee briefing information confirms that Modernas investigational Covid-19 vaccine (mRNA-1273) efficacy in preven...

JC Ayur Life Marketing Unapproved Drug: FDA

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FDA says JC Ayur Life is marketing a misbranded unapproved new drug as an herbal supplement.

Clinical Hold on Regeneron Odronextamab Trials

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Regeneron says it will submit an odronexamab trial protocol amendment to FDA in hopes of resuming trial enrollments in 2021.

Could SCOTUS Eliminate Levine?

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Attorneys Dick Dean and Emmanuel Sanders see the possibility that five Supreme Court justices would vote to overturn Wyeth v. Levi...