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Califf Says Evidence Generation is Mediocre At Best

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FDA commissioner Robert Califf says his tenure at FDA will focus on improving evidence generation, which he described as being med...

FDA, USPTO Outline Steps to Lower Drug Prices, Aid Competition

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The heads of FDA and the U.S. Patent and Trademark Office describe joint actions they are taking to lower drug prices and boost co...

PMA for Degenerative Spondylolisthesis Implant

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FDA accepts a PMA module from Empirical Spine for its LimiFlex Dynamic Sagittal Tether, a spinal implant for grade 1 degenerative ...

FDA De Novo Authorization for 2 Apollo Endoscope Systems

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FDA grants de novo marketing authorization for two Apollo Endosurgery endoscopic systems used in obese patients.

FDA Grants EUA for Novavax Covid Vaccine

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FDA grants an emergency use authorization for Novavaxs Covid-19 Vaccine, Adjuvanted for preventing disease caused by severe acute ...

AbbVies Rinvog Regulatory Review Determined

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for AbbVies Rinvoq (upadacitini...

FDA Clears Philips SmartSpeed Software

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FDA clears the Philips SmartSpeed MR acceleration software.

Citrus Plans I/ONTAK Lymphoma Drug BLA

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Citrus Pharmaceuticals says it will submit a BLA to FDA later this year for its I/ONTAK T-cell lymphoma treatment.

FDA Lifts Greenwich Flamingo-01 Trial Hold

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FDA lifts its clinical hold on a Greenwich LifeSciences Phase 3 trial of the companys invasive breast cancer investigational treat...

Catalyst Says Jacobus Patent Suit is Settled

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Catalyst says it has settled its patent litigation with Jacobus over Catalysts Firdapse and Jacobus Ruzurgi.