Regulatory Event

Priority Review

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

Recent events: 68
Catalysts: 1
Companies: 19

Recent events(68)

RegulatoryAugust 12, 2026

FDA grants priority review for ZAYNICH (NDA220787) by Wockhardt Bio AG

The FDA has granted priority review status to Wockhardt Bio AG's NDA for ZAYNICH, which contains zidebactam and cefepime.

RegulatoryAugust 10, 2026

AbbVie receives Priority Review for BLA761460 (Pivekimab Sunirine-PVZY)

AbbVie Inc. has submitted BLA761460 for Pivekimab Sunirine-PVZY, which is currently under Priority Review by the FDA. This submission is part of AbbVie's strategy to enhance its oncology portfolio, specifically targeting complex malignancies with monoclonal antibodies.

RegulatoryAugust 10, 2026

FDA grants priority review for Daiichi Sankyo's Datopotamab Deruxtecan (BLA761394)

Daiichi Sankyo's application BLA761394 for Datopotamab Deruxtecan-DLNK has received priority review status from the FDA.

RegulatoryAugust 10, 2026

Gilead Sciences receives Priority Review for Bulevirtide (HEPCLUDEX) BLA761468

Gilead Sciences has submitted Biologics License Application (BLA761468) for Bulevirtide (HEPCLUDEX) with Priority Review status.

RegulatoryAugust 10, 2026

AbbVie receives priority review for Linzess supplemental application

AbbVie submitted a supplemental application for Linaclotide (Linzess) under NDA202811, which is currently under priority review by the FDA.

RegulatoryAugust 9, 2026

FDA Grants Priority Review for Tecentriq Hybreza Submission

The FDA has granted priority review status for the supplemental biologics application BLA761347 for Tecentriq Hybreza, which combines atezolizumab and hyaluronidase-TQJS.

RegulatoryAugust 9, 2026

FDA Grants Priority Review for Tecentriq Supplement Application

The FDA has granted priority review for the supplemental Biologics License Application (BLA761034) for Tecentriq (atezolizumab) submitted by Genentech.

RegulatoryAugust 9, 2026

FDA Grants Priority Review for BAXFENDY (BAXDROSTAT) NDA219878

The FDA has granted priority review status for AstraZeneca's BAXFENDY, an application for BAXDROSTAT.

RegulatoryAugust 8, 2026

FDA Grants Priority Review for ENHERTU Supplement Application

The FDA has granted priority review status for the supplemental application of ENHERTU (BLA761139) by Daiichi Sankyo.

RegulatoryAugust 8, 2026

FDA Grants Priority Review for Takeda's ORZEYFUL (NDA 220860)

The FDA has granted priority review status for Takeda's new drug application for ORZEYFUL, containing OVEPOREXTON.

RegulatoryAugust 8, 2026

FDA Grants Priority Review for BEONE MEDICINES' BEQALZI (NDA220711)

The FDA has granted priority review status to BEONE MEDICINES' NDA for BEQALZI, containing sonrotoclax.

RegulatoryAugust 7, 2026

FDA Grants Priority Review for ZERBAXA Supplement NDA206829

The FDA has granted priority review status for the supplemental NDA for ZERBAXA, which includes cefotolozane sulfate and tazobactam sodium.

RegulatoryAugust 6, 2026

FDA Grants Priority Review for VYVGART Supplement Application

The FDA has granted priority review status for the supplemental application of VYVGART (BLA761195) by ARGENX BV.

RegulatoryAugust 6, 2026

FDA grants priority review for BLA761352 (ZENOCUTUZUMAB-ZBCO) by Merus N.V.

The FDA has granted priority review status for the supplemental biologics application BLA761352 for ZENOCUTUZUMAB-ZBCO.

RegulatoryAugust 6, 2026

FDA Grants Priority Review for OCREVUS Supplement Application

The FDA has granted priority review status for the supplemental application of OCREVUS (ocrelizumab) submitted by Genentech.

RegulatoryJuly 31, 2026

FDA Grants Priority Review for NUPLAZID Supplement NDA210793

The FDA has granted priority review status for the supplemental NDA for NUPLAZID, an indication for pimavanserin tartrate.

RegulatoryJuly 31, 2026

FDA grants priority review for NUPLAZID supplemental application

The FDA has granted priority review status for the supplemental application of NUPLAZID (pimavanserin tartrate) submitted by ACADIA Pharmaceuticals.

RegulatoryJuly 30, 2026

FDA Grants Priority Review for Otsuka's Simtriyo (Centanafadine)

The FDA has granted priority review status for Otsuka Pharmaceutical's NDA for Simtriyo, containing centanafadine.

RegulatoryJuly 29, 2026

FDA Grants Priority Review for Otsuka's Simtriyo (Centanafadine)

The FDA has granted priority review status for Otsuka's NDA for Simtriyo, an ADHD treatment containing centanafadine.

RegulatoryJuly 28, 2026

FDA Grants Priority Review for TZIELD (Teplizumab) Supplement

The FDA has granted priority review status for the supplemental Biologics License Application (BLA) for TZIELD (teplizumab) submitted by Provention Bio.

RegulatoryJuly 27, 2026

FDA Grants Priority Review for Cosentyx Supplement Application

The FDA has granted priority review for the supplemental biologics application for Cosentyx (secukinumab) submitted by Novartis.

RegulatoryJuly 24, 2026

FDA Grants Priority Review for TALZENNA Plus XTANDI in Metastatic Prostate Cancer

The FDA has accepted a supplemental New Drug Application for TALZENNA in combination with XTANDI for metastatic castration-sensitive prostate cancer, supported by Phase 3 TALAPRO-3 trial data.

RegulatoryJuly 23, 2026

FDA Grants Priority Review for Novartis' Fabhalta (Ipacopan Hydrochloride)

The FDA has granted priority review status for Novartis' NDA for Fabhalta, containing ipacopan hydrochloride.

RegulatoryJuly 23, 2026

FDA Grants Priority Review for LEQEMBI Supplement Application

The FDA has granted priority review status for the supplemental application of LEQEMBI (lecanemab-IRMB) submitted by Eisai Inc.

StrategyJuly 23, 2026

Roche Reports Strong H1 2026 Sales Growth and Multiple FDA Priority Reviews

Roche's pharmaceuticals division saw a 6% sales increase in H1 2026, driven by key products and multiple FDA Priority Reviews for new therapies.

StrategyJuly 23, 2026

Roche Reports Strong H1 2026 Sales and Multiple FDA Priority Reviews

Roche's H1 2026 sales increased by 6% at constant exchange rates, driven by strong demand for innovative medicines. The FDA granted Priority Reviews for five key therapies, including giredestrant for breast cancer and Enspryng for thyroid eye disease.

RegulatoryJuly 23, 2026

Roche Reports Strong H1 2026 Sales Growth and Multiple FDA Priority Reviews

Roche received five FDA Priority Reviews for key therapies including giredestrant for early-stage breast cancer and Enspryng for thyroid eye disease.

RegulatoryJuly 21, 2026

FDA Grants Priority Review for ZAYNICH NDA Submission by Wockhardt Bio AG

The FDA has granted priority review for the NDA submission of ZAYNICH, containing cefepime hydrochloride and zidebactam.

RegulatoryJuly 20, 2026

FDA Grants Priority Review for ABBVIE's BLA761460 (DECNUPAZ)

The FDA has granted priority review for ABBVIE's Biologics License Application for DECNUPAZ (BLA761460).

RegulatoryJuly 20, 2026

FDA Grants Priority Review for Datopotamab Deruxtecan Supplement

The FDA has granted priority review status for the supplemental application of Datopotamab Deruxtecan by Daiichi Sankyo.

RegulatoryJuly 20, 2026

FDA Grants Priority Review for BLA761468 (HEPCLUDEX) by Gilead Sciences

The FDA has granted priority review status for Gilead Sciences' BLA761468, known as HEPCLUDEX.

RegulatoryJuly 20, 2026

FDA Accepts Supplemental NDA for Linzess by AbbVie

The FDA has accepted a supplemental NDA for Linzess (linaclotide) submitted by AbbVie, indicating a priority review.

RegulatoryJuly 19, 2026

FDA Grants Priority Review for Tecentriq Hybreza Supplement Application

The FDA has granted priority review for the supplemental application of Tecentriq Hybreza, which combines atezolizumab with hyaluronidase.

RegulatoryJuly 18, 2026

FDA Grants Priority Review for Tecentriq Supplement Application

The FDA has granted priority review for the supplemental application of Tecentriq (atezolizumab) submitted by Genentech.

RegulatoryJuly 17, 2026

FDA Grants Priority Review for ENHERTU Supplement Application

The FDA has granted priority review for the supplemental application of ENHERTU (fam-trastuzumab deruxtecan-nxki) submitted by Daiichi Sankyo.

RegulatoryJuly 16, 2026

FDA Grants Priority Review for LEQEMBI Supplement Application

The FDA has granted priority review status for the supplemental application of LEQEMBI (lecanemab-IRMB) submitted by Eisai Inc.

RegulatoryJuly 16, 2026

FDA Grants Priority Review for BEQALZI (Sonrotoclax) NDA220711

The FDA has granted priority review status for BEQALZI, a novel therapy containing sonrotoclax, submitted by Beone Medicines USA.

RegulatoryJuly 15, 2026

FDA Grants Priority Review for KEYTRUDA QLEX Supplement Application

The FDA has accepted the supplemental application for KEYTRUDA QLEX, indicating a priority review status.

RegulatoryJuly 15, 2026

FDA grants priority review for PADCEV supplemental application

The FDA has accepted a supplemental application for PADCEV (enfortumab vedotin-ejfv) from Astellas, granting it priority review status.

RegulatoryJuly 15, 2026

FDA grants priority review for KEYTRUDA supplemental application

The FDA has granted priority review for the supplemental application of KEYTRUDA (pembrolizumab) submitted by Merck Sharp & Dohme.

RegulatoryJuly 15, 2026

FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for primary membranous nephropathy

The FDA has granted Priority Review for Gazyva/Gazyvaro based on phase III MAJESTY results showing significant remission rates in primary membranous nephropathy.

RegulatoryJuly 15, 2026

FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for primary membranous nephropathy

The FDA has granted Priority Review for Gazyva/Gazyvaro based on phase III MAJESTY results showing superior remission rates in primary membranous nephropathy.

RegulatoryJuly 15, 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.

RegulatoryJuly 14, 2026

FDA Grants Priority Review for ZERBAXA Supplement by Cubist Pharmaceuticals

The FDA has granted priority review status for the supplemental NDA for ZERBAXA, which includes cefotolozane sulfate and tazobactam sodium.

RegulatoryJuly 14, 2026

FDA Grants Priority Review for BIZENGRI Supplement by Merus N.V.

The FDA has granted priority review for the supplemental application of BIZENGRI (ZENOCUTUZUMAB-ZBCO) submitted by Merus N.V.

RegulatoryJuly 14, 2026

FDA Grants Priority Review for OCREVUS Supplemental Application

The FDA has granted priority review for the supplemental application of OCREVUS (ocrelizumab) submitted by Genentech.

RegulatoryJuly 14, 2026

FDA Grants Priority Review for VYVGART HYTRULO Supplement by ARGENX

The FDA has granted priority review status for the supplemental application of VYVGART HYTRULO, which contains Efgartigimod Alfa and Hyaluronidase-QVFC.

RegulatoryJuly 14, 2026

FDA Grants Priority Review for VYVGART Supplement Application

The FDA has granted priority review for the supplemental application of VYVGART (efgartigimod alfa) by Argenx BV.

RegulatoryJuly 12, 2026

FDA Grants Priority Review for TRUTAKNA (BLA761486) by Vera Therapeutics

The FDA has granted priority review status for TRUTAKNA, an application submitted by Vera Therapeutics.

RegulatoryJuly 10, 2026

FDA Grants Priority Review for KISQALI FEMARA Co-Packaged Product

The FDA has granted priority review for the co-packaged product KISQALI FEMARA, which includes letrozole and ribociclib succinate.

RegulatoryJuly 9, 2026

FDA Grants Priority Review for KISQALI Supplement by Novartis

The FDA has granted priority review for the supplemental NDA for KISQALI (ribociclib succinate) submitted by Novartis.

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.