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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...

Athenex NDA for Topical Actinic Keratosis Drug

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FDA approves an Athenex NDA for Klisyri (tirbanibulin) for the topical treatment of actinic keratosis on the face or scalp.

Spark Biomedical Breakthrough Status for Roo System

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FDA grants Spark Biomedical a Breakthrough Device Designation for the Roo System: a transcutaneous electrical nerve stimulator tha...

Senators Want Answers on Vaccine Option

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Some 20 Senate Democrats ask Operation Warp Speed leaders for answers to questions about the governments decision not to exercise ...

Mesoblast Rexlemestrocel-L Cuts Cardiac Deaths: Study

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Mesoblast says its rexlemestrocel-L reduced cardiac mortality in a Phase 3 trial of patients with advanced chronic heart failure.

ACLU Blasts Trump, FDA on Abortion Pill Requirement

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The ACLU again criticizes the Trump administration and FDA for requiring patients seeking access to the abortion pill to go to a h...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include JC Ayur Life and Desert Alchemist.