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BioNTech, COVID-19 and FDA

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The Pharma Letter · 1d
Pfizer and BioNTech win FDA approval for XFG-adapted COVID vaccine
US pharma major Pfizer and German biotech firm BioNTech have secured US Food and Drug Administration (FDA) clearance for the 2026-2027 formula of their COVID-19 vaccine Comirnaty (COVID-19 vaccine, mRNA),

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 · 1d
Pfizer and BioNTech Receive U.S. FDA Approval for XFG-adapted COVID-19 Vaccine
 · 1d · on MSN
FDA approves latest version of Pfizer's COVID-19 mRNA vaccine
 · 7h
Moderna Receives U.S. FDA Approval for Updated 2026-2027 COVID-19 Vaccines
Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2026-2027 formulas for Spikevax...

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 · 1d
FDA approves new COVID-19 shots
 · 1d
US FDA approves updated COVID vaccines for 2026-27 season
24/7 Wall St.
16h

BioNTech Tumbles 8% as Colorectal Cancer Vaccine Trial Fails, Moderna Drops 6%, Pfizer Holds Flat

BioNTech's colorectal cancer vaccine just collapsed in a Phase 2 trial, dragging Moderna down with it despite last week's melanoma triumph, and the fallout is forcing investors to rethink how far mRNA technology can actually reach into solid tumors.
BioSpace
15h

BioNTech halts mid-stage trial of personalized mRNA vaccine in colorectal cancer

Shares of Germany-based BioNTech were down as much as 8% Friday after announcing a Phase 2 trial of autogene cevumeran would be discontinued for futility. The news follows Merck and Moderna’s Phase 3 win last week for their cancer vaccine plus Keytruda in melanoma.
1mon

European Commission Authorizes Pfizer and BioNTech XFG-adapted COVID-19 Vaccine in the European Union

Data indicate that the 2026-2027 COVID-19 vaccine formula, targeting the XFG variant, induces a strong immune response against contemporary
1d

The Bull Case For Pfizer (PFE) Could Change Following New COVID And Lyme Vaccine Milestones - Learn Why

In August 2026, Pfizer and BioNTech received U.S. FDA approval for their updated COMIRNATY COVID-19 vaccine targeting the XFG variant for high-risk individuals, while Pfizer and Valneva’s Lyme disease vaccine candidate PF-07307405 had its Marketing Authorization Application validated by the European Medicines Agency based on Phase 3 trial data.
11h

BioNTech: Reiterating Strong Buy Based On COMIRNATY Variant Expansion And More

BioNTech SE maintains a Strong Buy rating, driven by robust late-stage oncology pipeline momentum and strategic partnerships. Click for more on BNTX.
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