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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...

Regulatory Review Period for Dr. Reddys Xeglyze

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Dr. Reddys Xeglyze (abameta...

Hikmas Reglan Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Hikma Pharmaceuticals Reglan (metoclopramide injection, USP) was not withdrawn due to...

FDA Authorizes Watmind At-Home Covid Antigen Test

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FDA grants an emergency use authorization to Watmind USA for its over-the-counter at-home Covid-19 antigen test.

Fresenius Propoven 2% Emulsion Authorization Revoked

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Federal Register notice: FDA revokes an Emergency Use Authorization issued to Fresenius Kabi USA for its Fresenius Propoven 2% Emu...

31 No-Longer-Marketed ANDAs Withdrawn

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Federal Register notice: FDA withdraws approval of 31 ANDAs from multiple applicants because the products are no longer marketed.