Pfizer and BioNTech Receive First U.S. Authorization for Emergency Use of COVID-19 Vaccine in Adolescents
May 11, 2021 02:30 ET
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BioNTech SE
In a Phase 3 trial, the vaccine was 100% effective and generally well tolerated in participants aged 12 to 15 years Data also submitted to European Medicines Agency (EMA) and other global regulators,...
Pfizer und BioNTech erhalten erste US-Notfallzulassung eines COVID-19-Impfstoffs für Jugendliche
May 11, 2021 02:30 ET
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BioNTech SE
Der Impfstoff war bei 12- bis 15-jährigen Teilnehmern einer Phase-3-Studie zu 100 % wirksam und generell gut verträglichDie Daten wurden bereits bei der Europäischen Arzneimittel-Agentur (EMA) und...
Eko’s AI Analysis Algorithm Validated as a Clinical Tool for Detecting Heart Murmurs
May 10, 2021 08:00 ET
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Eko
OAKLAND, Calif., May 10, 2021 (GLOBE NEWSWIRE) -- Eko, a cardiopulmonary digital health company, today announced the peer-reviewed publication of a clinical study that found that the Eko artificial...
Auris Medical Provides Update on Bentrio Program in Allergy
May 07, 2021 09:05 ET
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Auris Medical AG
BentrioTM meets primary efficacy endpoint in clinical evaluation in allergic rhinitisClinically relevant and significant reduction in nasal symptomsSuperior efficacy ratings by patients and clinicians...
Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of their COVID-19 Vaccine
May 07, 2021 06:45 ET
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BioNTech SE
NEW YORK and MAINZ, GERMANY, May 7, 2021 (GLOBE NEWSWIRE) — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics License Application (BLA) with the U.S....
Pfizer und BioNTech beginnen rollierenden Einreichungsprozess einer Biologics License Application für die volle Zulassung ihres COVID-19-Impfstoffs bei der FDA
May 07, 2021 06:45 ET
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BioNTech SE
NEW YORK, USA und MAINZ, DEUTSCHLAND, 07. Mai 2021 —Pfizer Inc. (NYSE: PFE) und BioNTech SE (Nasdaq: BNTX) gaben heute bekannt, dass sie die Einreichung des Antrags für die vollständige Zulassung...
FDA Grants RenovaCare Full IDE Approval for Safety and Feasibility Clinical Trial
May 06, 2021 08:30 ET
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RenovaCare, Inc.
ROSELAND, N.J., May 06, 2021 (GLOBE NEWSWIRE) -- RenovaCare, Inc. (Symbol: RCAR; www.renovacareinc.com), today announced that its Investigational Device Exemption (IDE) application has been granted...
QSAM Biosciences Announces Submission of IND Application for CycloSam® with FDA
May 04, 2021 09:00 ET
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QSAM Biosciences Inc.
Austin, TX, May 04, 2021 (GLOBE NEWSWIRE) -- QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next-generation nuclear medicines for the treatment of cancer and related diseases, announced...
Protocol Complexity and Patient Enrollment Intensify Challenges in Oncology Clinical Trials, According to Tufts Center for the Study of Drug Development
May 04, 2021 09:00 ET
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Tufts Center for the Study of Drug Development
BOSTON, May 04, 2021 (GLOBE NEWSWIRE) -- Increasing complexity of clinical trials targeting cancer—including use of more sophisticated scientific designs, larger global scope, and greater focus on...
Curium Announces Filing of a Generic Version of DaTscanᵀᴹ (Ioflupane I 123 Injection) in the U.S.
May 04, 2021 02:30 ET
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Curium
St. Louis, MO, May 04, 2021 (GLOBE NEWSWIRE) -- Curium announced today that it submitted an abbreviated new drug application for a generic version of DaTscan (Ioflupane I 123 Injection) with the...