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Tech·Science

FDA approvals in July

Market icon
Tech·Science

FDA approvals in July

Ended: juil. 31, 2025

Ended: juil. 31, 2025

$108,387 Vol.

31 juil. 2025
Polymarket

$108,387 Vol.

Polymarket

RP1 (BLA)

$78,750 Vol.

No

Blenrep (BLA)

$13,076 Vol.

No

TransCon hGH (sBLA)

$3,355 Vol.

Yes

Aficamten (NDA)

$8,017 Vol.

No

Empaveli (sNDA)

$852 Vol.

Yes

Sepiapterin (NDA)

$3,598 Vol.

Yes

Odronextamab/Ordspono (Resubmitted BLA)

$739 Vol.

No

This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for the listed drug by July 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 the listed drug by July 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.
Volume
$108,387
Date de fin
31 juil. 2025
Marché ouvert
Jul 21, 2025, 7:40 PM ET

Resolver

0x157Ce2d67...
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for the listed drug by July 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.

Résultat proposé: No

Aucune contestation

Résultat final: No

This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for the listed drug by July 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 the listed drug by July 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.
Volume
$108,387
Date de fin
31 juil. 2025
Marché ouvert
Jul 21, 2025, 7:40 PM ET

Resolver

0x157Ce2d67...
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for the listed drug by July 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.

Résultat proposé: No

Aucune contestation

Résultat final: No

Méfiez-vous des liens externes.

Questions fréquentes

« FDA approvals in July » est un marché de prédiction sur Polymarket avec 7 résultats possibles où les traders achètent et vendent des parts selon ce qu'ils pensent qu'il se passera. Le résultat en tête actuel est « TransCon hGH (sBLA) » à 100%, suivi de « Empaveli (sNDA) » à 100%. Les prix reflètent des probabilités en temps réel de la communauté. Par exemple, une part cotée à 100¢ implique que le marché attribue collectivement une probabilité de 100% à ce résultat. Ces cotes changent en permanence. Les parts du résultat correct sont échangeables contre $1 chacune lors de la résolution du marché.

À ce jour, « FDA approvals in July » a généré $108.4K en volume total de trading depuis le lancement du marché le Jul 21, 2025. Ce niveau d'activité reflète un fort engagement de la communauté Polymarket et garantit que les cotes actuelles sont alimentées par un large bassin de participants. Vous pouvez suivre les mouvements de prix en direct et trader sur n'importe quel résultat directement sur cette page.

Pour trader sur « FDA approvals in July », parcourez les 7 résultats disponibles sur cette page. Chaque résultat affiche un prix actuel représentant la probabilité implicite du marché. Pour prendre position, sélectionnez le résultat que vous estimez le plus probable, choisissez « Oui » pour trader en sa faveur ou « Non » pour trader contre, entrez votre montant et cliquez sur « Trader ». Si votre résultat choisi est correct lors de la résolution, vos parts « Oui » rapportent $1 chacune. S'il est incorrect, elles rapportent $0. Vous pouvez également vendre vos parts avant la résolution.

Le favori actuel pour « FDA approvals in July » est « TransCon hGH (sBLA) » à 100%, ce qui signifie que le marché attribue une probabilité de 100% à ce résultat. Le résultat le plus proche ensuite est « Empaveli (sNDA) » à 100%. Ces cotes sont mises à jour en temps réel à mesure que les traders achètent et vendent des parts. Revenez fréquemment ou ajoutez cette page à vos favoris.

Les règles de résolution de « FDA approvals in July » définissent exactement ce qui doit se produire pour que chaque résultat soit déclaré gagnant, y compris les sources de données officielles utilisées pour déterminer le résultat. Vous pouvez consulter les critères de résolution complets dans la section « Règles » sur cette page au-dessus des commentaires. Nous recommandons de lire attentivement les règles avant de trader, car elles précisent les conditions exactes, les cas particuliers et les sources.