Tag: Authorization

Merck and Ridgeback Announce Submission of Emergency Use Authorization Application to the U.S. FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults | Small Molecules
October 12, 2021

Merck and Ridgeback Announce Submission of Emergency Use Authorization Application to the U.S. FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults | Small Molecules

Merck and Ridgeback announce the filing of an emergency filing with the U.S. FDA for molnupiravir, an investigational oral antiviral drug used to treat mild to moderate COVID-19 in at-risk adults Details Category: Small Molecules Posted on Monday, October 11, 2021 6:43 PM Hits: 210 If approved, molnupiravir could become the first oral antiviral drug to treat COVID-19. be Filings …
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Merck and Ridgeback Announce Submission of Emergency Use Authorization Application to the U.S. FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults
October 11, 2021

Merck and Ridgeback Announce Submission of Emergency Use Authorization Application to the U.S. FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults

KENILWORTH, NJ & MIAMI–(GESCHÄFTSDRAHT)–Merck (NYSE: MRK), außerhalb der Vereinigten Staaten und Kanadas als MSD bekannt, und Ridgeback Biotherapeutics gaben heute bekannt, dass Merck bei der US-amerikanischen Food and Drug Administration (FDA) einen Zulassungsantrag für den Notfall (EUA) für Molnupiravir eingereicht hat. ein orales antivirales Prüfarzneimittel zur Behandlung von leichtem bis mittelschwerem COVID-19 bei Erwachsenen, bei denen das Risiko besteht, zu …
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BioMarin Resubmits Marketing Authorization Application (MAA) to European Medicines Agency for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A
June 30, 2021

BioMarin Resubmits Marketing Authorization Application (MAA) to European Medicines Agency for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A

SAN RAFAEL, CALIFORNIA., June 28, 2021 / PRNewswire / – BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that it has re-submitted a MAA from the European Medicines Agency (EMA) for its investigational therapy Valoctocogen roxaparvovec for adults with severe hemophilia A. submitted. in the May 2021, the EMA has granted the company’s accelerated assessment request. An accelerated assessment may shorten …
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