Regulatory Event

Priority Review

FDA Priority Review status that shortens the standard review clock for therapies with significant clinical benefit.

Recent events: 17
Catalysts: 1
Companies: 6

Recent events(17)

RegulatoryJuly 5, 2026

FDA Grants Priority Review for TZIELD (Teplizumab-MZWV) Supplement

The FDA has granted priority review for the supplemental application of TZIELD (Teplizumab-MZWV) by Provention Bio.

RegulatoryJune 30, 2026

FDA Grants Priority Review for Roche's Enspryng in Thyroid Eye Disease

The FDA has granted priority review for Roche's Enspryng (satralizumab) as a treatment for thyroid eye disease, based on positive phase III trial results.

RegulatoryJune 30, 2026

FDA Grants Priority Review for Roche's Enspryng in Thyroid Eye Disease

The FDA has granted priority review for Roche's Enspryng (satralizumab) for treating thyroid eye disease, based on positive phase III trial results.

RegulatoryJune 27, 2026

FDA Grants Priority Review for TRYNGOLZA Autoinjector Submission

The FDA has granted priority review for the supplemental application of TRYNGOLZA (olezarsen sodium) autoinjector by Ionis Pharmaceuticals.

RegulatoryJune 26, 2026

FDA Grants Priority Review for ZEGALOGUE Supplemental Application

The FDA has granted priority review status for the supplemental application of ZEGALOGUE (dasiglucagon hydrochloride) submitted by Zealand Pharma.

RegulatoryJune 23, 2026

FDA Grants Priority Review for UTEBZI (TEBIPENEM, PIVOXIL) by GlaxoSmithKline

The FDA has granted priority review status for NDA215960 for UTEBZI, an antibiotic containing TEBIPENEM and PIVOXIL.

RegulatoryJune 22, 2026

FDA Grants Priority Review for Pfizer's Marstacimab (BLA761369)

The FDA has granted priority review status for Pfizer's BLA761369, containing the active ingredient Marstacimab.

RegulatoryJune 21, 2026

FDA Grants Priority Review for Pfizer's Marstacimab (HYMPAVZI) Supplement

The FDA has granted priority review status for the supplemental application of Marstacimab (HYMPAVZI) by Pfizer.

RegulatoryJune 20, 2026

FDA Grants Priority Review for TZIELD (Teplizumab) Supplement

The FDA has granted priority review for the supplemental application of TZIELD (Teplizumab) by Provention Bio.

RegulatoryJune 20, 2026

FDA Grants Priority Review for Welireg Supplement from Merck

The FDA has granted priority review for the supplemental NDA for Welireg (belzutifan) submitted by Merck.

RegulatoryJune 18, 2026

FDA Grants Priority Review for KEYTRUDA QLEX Supplement Application

The FDA has granted priority review for the supplemental application of KEYTRUDA QLEX, which includes pembrolizumab and berahyaluronidase alfa-PMPH.

RegulatoryJune 18, 2026

FDA Grants Priority Review for Welireg Supplement NDA215383

The FDA has granted priority review for the supplemental NDA for Welireg (belzutifan) submitted by Merck Sharp Dohme.

RegulatoryJune 17, 2026

Ifinatamab Deruxtecan Receives Priority Review for ES-SCLC in the U.S.

Ifinatamab deruxtecan's Biologics License Application has been accepted and granted Priority Review by the FDA for ES-SCLC.

RegulatoryJune 17, 2026

FDA Grants Priority Review for KEYTRUDA and KEYTRUDA QLEX in MIBC Treatment

The FDA has granted priority review for KEYTRUDA and KEYTRUDA QLEX in combination with Padcev for muscle-invasive bladder cancer.

RegulatoryJune 16, 2026

FDA Accepts NDA for Roche's Giredestrant in Early-Stage ER-Positive Breast Cancer

The FDA has accepted Roche's NDA for giredestrant, an oral SERD, under priority review based on phase III data showing a 30% reduction in invasive disease recurrence or death compared to standard therapy.

RegulatoryJune 11, 2026

FDA Grants Priority Review for Roche’s Tecentriq in Stage III Colon Cancer

The FDA has accepted Roche's sBLA for Tecentriq plus chemotherapy in stage III dMMR/MSI-H colon cancer, with a decision expected by October 9, 2026.

RegulatoryJune 11, 2026

FDA grants Priority Review for Roche’s Tecentriq in stage III colon cancer

The FDA has accepted Roche's sBLA for Tecentriq in combination with chemotherapy for stage III dMMR/MSI-H colon cancer, with a decision expected by October 9, 2026.

Historical activity(1)

Priority Review

Roche — Tecentriq

Priority review accelerates competitive pressure in adjuvant IO colon cancer.

June 28, 2026 · NDA/BLA

Related companies

GSK →

Ionis Pharmaceuticals →

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