Luminostics Announces FDA Authorization and Production Scale-Up of US-Manufactured Smartphone-Based COVID-19 Rapid Test
February 16, 2021 05:30 ET | Luminostics
Luminostics’s Clip COVID Rapid Antigen Test uses a smartphone-based analyzer to obtain results in 30 minutes from nasal swabs in decentralized settingsClip COVID’s emergency use authorization (EUA) in...
MATEON ANNOUNCES COMPLETION OF ARTI-19 AND PUBLICATION OF POSITIVE INTERIM DATA
February 02, 2021 07:00 ET | Mateon Therapeutics, Inc.
AGOURA HILLS, California, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Mateon Therapeutics, Inc. (OTCQB:MATN) (“Mateon”), a leading developer of TGF-β therapeutics for oncology and infectious diseases,...
Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19
December 11, 2020 23:15 ET | BioNTech SE
U.S. FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. immediatelyPfizer and BioNTech previously announced an agreement with the U.S....
Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use Authorization for Vaccine to Combat COVID-19 in the U.S.
December 10, 2020 18:51 ET | BioNTech SE
FDA expected to make a decision on Emergency Use Authorization in the coming daysPositive vote based on totality of scientific evidence presented by the companies, including Phase 3 efficacy and...
FDA-Beratungsausschuss unterstützt die erste U.S.-Notfallzulassung für Pfizers und BioNTechs COVID-19-Impfstoff
December 10, 2020 18:51 ET | BioNTech SE
FDA wird voraussichtlich innerhalb der nächsten Tage eine Entscheidung bezüglich einer Notfallzulassung treffenDas positive Abstimmungsergebnis basiert auf der Gesamtheit der eingereichten...
Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19
December 02, 2020 02:05 ET | BioNTech SE
U.K. regulator, MHRA, authorizes supply of COVID-19 mRNA vaccine for emergency supply under Regulation 174; Companies are ready to deliver the first doses to the U.K. immediatelyFirst authorization...
Pfizer und BioNTech erhalten weltweit erste Zulassung für COVID-19-Impfstoff
December 02, 2020 02:05 ET | BioNTech SE
Die britische Regulierungsbehörde MHRA genehmigt die Lieferung von COVID-19-Impfstoff zur Notfallversorgung (gemäß Verordnung 174); erste Lieferungen werden innerhalb weniger Tage im Vereinigten...
Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine
November 20, 2020 06:45 ET | BioNTech SE
In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the globe including in Australia, Canada, Europe, Japan and the U.K., and plan to submit...
Pfizer und BioNTech reichen Antrag auf Notfallzulassung für COVID-19-Impfstoff bei der U.S. FDA ein
November 20, 2020 06:45 ET | BioNTech SE
Neben der heutigen Einreichung bei der FDA haben die Unternehmen bereits eine rollierende Einreichung für den Review-Prozess bei Behörden weltweit gestartet, einschließlich Australien, Kanada, Europa,...
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Precipio Announces Commercial Launch of COVID-19 Antibody Test
July 30, 2020 10:15 ET | Precipio, Inc.
NEW HAVEN, Conn., July 30, 2020 (GLOBE NEWSWIRE) -- Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO), is announcing its COVID-19 strategy, and its intent to contribute to the battle...