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icon for FDA approves EYLEA HD?
Technologia·Drug

FDA approves EYLEA HD?

icon for FDA approves EYLEA HD?
Technologia·Drug

FDA approves EYLEA HD?

Ended: Aug 19, 2025

May 29

May 31

Ended: Aug 19, 2025

May 29

May 31

1% szansa
Polymarket

$5,930 Wol.

1% szansa
Polymarket

$5,930 Wol.

This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Regeneron Pharmaceuticals' and Bayer AG's EYLEA HD (aflibercept 8 mg) as a treatment for macular edema following retinal vein occlusion and to expand the dosing schedule to include every 4-week dosing across approved indications by August 31, 2025, 11:59 PM ET. Otherwise, this market will resolve to "No." An approval is defined as: For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA) For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA) For biosimilars: FDA approval of a 351(k) application The following constitute qualifying approvals: Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs The following do not constitute qualifying approvals: Approvable letters that require additional actions before approval Tentative approvals pending patent or exclusivity expiration FDA requests for additional information or studies Extension of Prescription Drug User Fee Amendments dates Approval for compassionate use or expanded access programs only Approval only for export or for use outside the United States Emergency Use Authorization (EUA) without full approval Complete Response Letters (CRLs) indicating the application cannot be approved in its current form This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the month, the market will resolve to "No" immediately. If the listed drug is approved before the end of the month, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval. Conditional approvals may include post-marketing requirements or commitments and still qualify. The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.

This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Regeneron Pharmaceuticals' and Bayer AG's EYLEA HD (aflibercept 8 mg) as a treatment for macular edema following retinal vein occlusion and to expand the dosing schedule to include every 4-week dosing across approved indications by August 31, 2025, 11:59 PM ET. Otherwise, this market will resolve to "No."

An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application

The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs

The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Amendments dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form

This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the month, the market will resolve to "No" immediately.

If the listed drug is approved before the end of the month, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.

Conditional approvals may include post-marketing requirements or commitments and still qualify.

The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.
Wolumen
$5,930
Data zakończenia
Aug 19, 2025
Rynek otwarty
Jul 29, 2025, 11:27 AM ET

Resolver

0x157Ce2d67...
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Regeneron Pharmaceuticals' and Bayer AG's EYLEA HD (aflibercept 8 mg) as a treatment for macular edema following retinal vein occlusion and to expand the dosing schedule to include every 4-week dosing across approved indications by August 31, 2025, 11:59 PM ET. Otherwise, this market will resolve to "No." An approval is defined as: For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA) For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA) For biosimilars: FDA approval of a 351(k) application The following constitute qualifying approvals: Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs The following do not constitute qualifying approvals: Approvable letters that require additional actions before approval Tentative approvals pending patent or exclusivity expiration FDA requests for additional information or studies Extension of Prescription Drug User Fee Amendments dates Approval for compassionate use or expanded access programs only Approval only for export or for use outside the United States Emergency Use Authorization (EUA) without full approval Complete Response Letters (CRLs) indicating the application cannot be approved in its current form This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the month, the market will resolve to "No" immediately. If the listed drug is approved before the end of the month, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval. Conditional approvals may include post-marketing requirements or commitments and still qualify. The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.

Wynik zaproponowany: No

Brak sporu

Ostateczny wynik: No

This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Regeneron Pharmaceuticals' and Bayer AG's EYLEA HD (aflibercept 8 mg) as a treatment for macular edema following retinal vein occlusion and to expand the dosing schedule to include every 4-week dosing across approved indications by August 31, 2025, 11:59 PM ET. Otherwise, this market will resolve to "No." An approval is defined as: For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA) For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA) For biosimilars: FDA approval of a 351(k) application The following constitute qualifying approvals: Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs The following do not constitute qualifying approvals: Approvable letters that require additional actions before approval Tentative approvals pending patent or exclusivity expiration FDA requests for additional information or studies Extension of Prescription Drug User Fee Amendments dates Approval for compassionate use or expanded access programs only Approval only for export or for use outside the United States Emergency Use Authorization (EUA) without full approval Complete Response Letters (CRLs) indicating the application cannot be approved in its current form This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the month, the market will resolve to "No" immediately. If the listed drug is approved before the end of the month, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval. Conditional approvals may include post-marketing requirements or commitments and still qualify. The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.

This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Regeneron Pharmaceuticals' and Bayer AG's EYLEA HD (aflibercept 8 mg) as a treatment for macular edema following retinal vein occlusion and to expand the dosing schedule to include every 4-week dosing across approved indications by August 31, 2025, 11:59 PM ET. Otherwise, this market will resolve to "No."

An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application

The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs

The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Amendments dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form

This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the month, the market will resolve to "No" immediately.

If the listed drug is approved before the end of the month, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.

Conditional approvals may include post-marketing requirements or commitments and still qualify.

The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.
Wolumen
$5,930
Data zakończenia
Aug 19, 2025
Rynek otwarty
Jul 29, 2025, 11:27 AM ET

Resolver

0x157Ce2d67...
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Regeneron Pharmaceuticals' and Bayer AG's EYLEA HD (aflibercept 8 mg) as a treatment for macular edema following retinal vein occlusion and to expand the dosing schedule to include every 4-week dosing across approved indications by August 31, 2025, 11:59 PM ET. Otherwise, this market will resolve to "No." An approval is defined as: For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA) For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA) For biosimilars: FDA approval of a 351(k) application The following constitute qualifying approvals: Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs The following do not constitute qualifying approvals: Approvable letters that require additional actions before approval Tentative approvals pending patent or exclusivity expiration FDA requests for additional information or studies Extension of Prescription Drug User Fee Amendments dates Approval for compassionate use or expanded access programs only Approval only for export or for use outside the United States Emergency Use Authorization (EUA) without full approval Complete Response Letters (CRLs) indicating the application cannot be approved in its current form This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the month, the market will resolve to "No" immediately. If the listed drug is approved before the end of the month, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval. Conditional approvals may include post-marketing requirements or commitments and still qualify. The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.

Wynik zaproponowany: No

Brak sporu

Ostateczny wynik: No

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