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Moderna Begins Dosing in Phase 3 Covid Vaccine Trial

[ Price : $8.95]

Moderna says it has begun dosing participants in its Phase 3 study of its mRNA vaccine candidate for Covid-19.

Indivior Pays $600 Million in Opioid Marketing Case

[ Price : $8.95]

Indivior Solutions pleads guilty to one felony count and agrees to pay a total of $600 million to resolve criminal and civil liabi...

More Data Requested to Lift Hold on Solid Duchenne Drug

[ Price : $8.95]

FDA requests additional data and manufacturing information from Solid Biosciences to potentially lift a clinical hold on the compa...

LabCorp EUA Covers Asymptomatic, Pooled Covid Samples

[ Price : $8.95]

FDA reissues an emergency use authorization to LabCorp for its Covid-19 RT-PCR Test to include two new indications for use testin...

Stratus Vesta RF Cannula Cleared for Pain Relief

[ Price : $8.95]

FDA clears a Stratus Medical 510(k) for the Vesta RF Cannula for use in radiofrequency heat lesion procedures for relieving pain.

FDA Orders 10-year Debarment of Park

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Federal Register notice: FDA issues a 10-year debarment order against Jin Su Park for importing misbranded drugs into the U.S.

Laing Permanently Debarred by FDA

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Federal Register notice: FDA permanently debars Euton M. Laing from providing services in any capacity to a person that has an app...

Seil Debarred for 10 Years by FDA

[ Price : $8.95]

Federal Register notice: FDA issues a 10-year debarment order against John Seil from importing or offering for import any drug int...

AstraZenecas Breztri Approved for COPD

[ Price : $8.95]

FDA approves an AstraZeneca NDA for Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the maintenance treatme...

MyoKardia Gets Breakthrough Status for Mavacamten

[ Price : $8.95]

FDA grants MyoKardia a breakthrough therapy designation for mavacamten, an oral, allosteric modulator of cardiac myosin for treati...