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Athenex NDA for Topical Actinic Keratosis Drug

[ Price : $8.95]

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

[ Price : $8.95]

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.

Foldax IDE Approved for New Heart Valve

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FDA approves a Foldax IDE to begin a clinical study of its Tria biopolymer mitral surgical heart valve.

Gannex Gets Fast Track for NASH Drug

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FDA grants Gannex a fast track designation for its non-alcoholic steatohepatitis (NASH) drug candidate ASC42, which the company de...

Genentech Gains Shorter Infusion Time with MS Drug

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FDA approves a shorter two-hour infusion time for Genentechs Ocrevus (ocrelizumab) dosed twice-yearly for those living with relap...

Not All Scrubs are Medical Devices: Petition

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A just-filed citizen petition requests that FDA not treat daily-wear uniform scrubs as medical devices.