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Teknolohiya·Science

FDA approvals in July

icon for FDA approvals in July
Teknolohiya·Science

FDA approvals in July

Ended: Jul 31, 2025

Apr 30

Apr 30

May 18

Ended: Jul 31, 2025

Apr 30

Apr 30

May 18

$108,387 Vol.

Jul 31, 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
Petsa ng Pagtatapos
Jul 31, 2025
Binuksan ang Market
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.

Na-propose ang outcome: No

Walang dispute

Pinal na outcome: 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
Petsa ng Pagtatapos
Jul 31, 2025
Binuksan ang Market
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.

Na-propose ang outcome: No

Walang dispute

Pinal na outcome: No

Mag-ingat sa mga external link.

Mga Madalas na Tanong

Ang "FDA approvals in July" ay isang prediction market sa Polymarket na may 7 posibleng outcomes kung saan bumibili at nagbebenta ang mga trader ng shares batay sa kanilang pinaniniwalaan na mangyayari. Ang kasalukuyang nangunguna ay "TransCon hGH (sBLA)" sa 100%, sinusundan ng "Empaveli (sNDA)" sa 100%. Ang mga presyo ay sumasalamin sa real-time crowd-sourced probabilities. Halimbawa, ang isang share na naka-presyo sa 100¢ ay nagpapahiwatig na kolektibong itinatakda ng market ang 100% na tsansa sa outcome na iyon. Patuloy na nagbabago ang mga odds na ito habang tumutugon ang mga trader sa mga bagong development at impormasyon. Ang mga shares sa tamang outcome ay mare-redeem sa $1 bawat isa sa market resolution.

Sa ngayon, ang "FDA approvals in July" ay naka-generate ng $108.4K sa kabuuang trading volume mula nang ilunsad ang market noong Jul 21, 2025. Ang antas na ito ng trading activity ay sumasalamin sa malakas na engagement mula sa Polymarket community at tumutulong na matiyak na ang kasalukuyang odds ay sinusuportahan ng malawak na pool ng mga market participant. Maaari mong subaybayan ang live price movements at mag-trade sa anumang outcome nang direkta sa pahinang ito.

Para mag-trade sa "FDA approvals in July," i-browse ang 7 available na outcomes na nakalista sa pahinang ito. Ang bawat outcome ay may kasalukuyang presyo na kumakatawan sa implied probability ng market. Para kumuha ng posisyon, piliin ang outcome na pinaniniwalaan mong pinaka-malamang, piliin ang "Yes" para mag-trade pabor dito o "No" para mag-trade laban dito, ilagay ang iyong halaga, at i-click ang "Trade." Kung tama ang iyong napiling outcome kapag na-resolve ang market, nagbabayad ang iyong "Yes" shares ng $1 bawat isa. Kung mali, nagbabayad ang mga ito ng $0. Maaari ka ring magbenta ng iyong shares anumang oras bago ang resolution kung gusto mong i-lock in ang kita o bawasan ang pagkalugi.

Ang kasalukuyang frontrunner para sa "FDA approvals in July" ay "TransCon hGH (sBLA)" sa 100%, ibig sabihin itinatakda ng market ang 100% na tsansa sa outcome na iyon. Ang sumunod na pinaka-malapit na outcome ay "Empaveli (sNDA)" sa 100%. Nag-a-update ang mga odds na ito sa real-time habang bumibili at nagbebenta ang mga trader ng shares, kaya sinasalamin nila ang pinakabagong kolektibong view kung ano ang pinaka-malamang na mangyari. Bumalik nang madalas o i-bookmark ang pahinang ito para sundan kung paano nagbabago ang odds habang lumilitaw ang bagong impormasyon.

Ang mga resolution rules para sa "FDA approvals in July" ay tiyak na nagde-define kung ano ang kailangang mangyari para sa bawat outcome na maideklara bilang panalo — kasama ang mga opisyal na data source na ginagamit para matukoy ang resulta. Maaari mong i-review ang kumpletong resolution criteria sa "Rules" section sa pahinang ito sa itaas ng mga komento. Inirerekomenda namin na basahin nang mabuti ang mga patakaran bago mag-trade, dahil tinutukoy nila ang mga tiyak na kondisyon, edge cases, at mga source na namamahala kung paano nise-settle ang market na ito.