Pending FDA decisions to watch

Decisions expected soon

• Mitapivat for sickle cell disease: FDA decision status
  Developer: Agios Pharmaceuticals. FDA goal date: 1 November 2026. Already approved in the US for pyruvate kinase deficiency (Pyrukynd) and thalassemia (Aqvesme).
• Ivonescimab for EGFR-mutated lung cancer: FDA decision status
  US sponsor: Summit Therapeutics (developed by Akeso). FDA goal date: 14 November 2026. Approved in China since May 2024.

What is a PDUFA goal date?

When the FDA accepts an application for a new medicine or a new use, it sets a target date for its decision under the Prescription Drug User Fee Act (PDUFA). The FDA may act on or before that date, and the date can move if the review is extended. The developer usually announces the outcome. Until then, the medicine is not approved for that use in the US.

Can a patient get a medicine before the FDA decides?

Before approval, a medicine is normally available only in clinical trials or through the developer's expanded access program, if one exists. The treating physician makes the request, and the developer and the FDA must agree. Reserve Meds coordinates access to FDA-approved medicines only, so we can explain the expanded access route but we do not supply investigational medicines. FDA: expanded access.

Already approved in the US but not in the Gulf?

See our tracker of 50 recent FDA approvals and whether each appears in the Saudi SFDA list and the Abu Dhabi DoH list.

This page is general information, not medical advice. Treatment decisions belong to the patient's own physician and the relevant regulator. Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner.

Reviewed by the Reserve Meds clinical operations team. Last reviewed 17 October 2026. Editorial standards.