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11.02.26 - 22:03
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FDA Refuses To Review Moderna′s Application For Experimental Flu Shot (ZeroHedge)
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FDA Refuses To Review Moderna's Application For Experimental Flu Shot
Authored by Troy Myers via The Epoch Times,
The Food and Drug Administration (FDA) is refusing to review Moderna's experimental flu shot, the company announced Tuesday.
Already submitted and accepted for review in the European Union, Canada, and Australia, the experimental shot's application being denied by the FDA is another sign of President Donald Trump's administration's impact on U.S. pharmaceutical companies.
FDA Center for Biologics Evaluation and Research (CBER) Director Vinayak Prasad signed the refusal to review letter, objecting to Moderna's study design and its lack of an “adequate and well-controlled” study.
Moderna's CEO refuted to Prasad's assessment.
“It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting,” Moderna CEO Stéphane Bancel ...
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11.02.26 - 16:37
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Moderna Aktie: FDA stoppt Grippeimpfstoff-Antrag, Break-even rutscht auf 2030 (Aktiencheck)
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Charlotte (www.aktiencheck.de) - Moderna-Aktienanalyse der Bank of America (BofA):
BofA habe das Kursziel für die Aktie von Moderna Inc. (ISIN: US60770K1079, WKN: A2N9D9, Ticker-Symbol: 0QF, NASDAQ-Symbol: MRNA) von 27 auf 24 USD gesenkt und das Rating "underperform" beibehalten. Der Biotech-Konzern mitgeteilt, dass es für den BLA-Zulassungsantrag seines Grippeimpfstoffs mRNA-1010 ein sogenanntes "Refuse-to-File"-Schreiben erhalten habe. [mehr]...
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11.02.26 - 16:15
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FDA refusing to review Moderna mRNA flu shot application (The Hill)
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Moderna said on Tuesday that the Food and Drug Administration (FDA) has refused to review its application for an mRNA flu vaccine, with the company claiming this decision is inconsistent with previous communications from the agency. In a press release Tuesday, Moderna said the FDA's Center for Biologics Evaluation and Research (CBER) told the company......
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11.02.26 - 11:45
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Moderna-Aktie -9%: Trotz der Hiobsbotschaft kaufen? (Sharedeals)
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Nachdem die Moderna-Aktie bereits in den letzten zwei Handelswochen den Rückwärtsgang eingeschaltet hat, bricht sie am Mittwochmorgen um -9% im europäischen Handel ein. Was für eine Hiobsbotschaft steckt hinter dem Kurseinbruch und müssen sich Anleger nun Sorgen machen? Widerstand der FDA Es ist in der Tat eine Nachricht, die Moderna-Aktionäre nicht gerne gehört haben werden. […]
The post Moderna-Aktie -9%: Trotz der Hiobsbotschaft kaufen? first appeared on sharedeals.de....
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