Vimseltinib (New Molecular Entity)

Developer: Deciphera (Ono Pharmaceutical)
Modality: Small Molecule
PDUFA Date: February 17, 2025
Indication / Description: Cancer / For the treatment of tenosynovial giant cell tumor (TGCT) patients
Review Type: Priority Review
Application Submission Time: June 2024

Review Status: FDA accepted application on August 15, 2024

Mirdametinib (New Molecular Entity)

Developer: SpringWorks Therapeutics
Modality: Small Molecule
PDUFA Date: February 18, 2025
Indication / Description: Cancer / For the treatment of children and adults with neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas (NF1-PN)
Review Type: Priority Review
Application Submission Time: June 2024

Review Status: FDA accepted application on August 15, 2024

ET-400 (Hydrocortisone Oral Solution)

Developer: Eton Pharmaceuticals
Modality: Small Molecule
PDUFA Date: February 28, 2025
Indication / Description: Endocrine, Immunology / A novel oral solution form of hydrocortisone (also known as hydrocortisone), stable at room temperature, for infants and pediatric patients
Review Type: 505(b)(2) NDA Standard Review
Application Submission Time: April 30, 2024

Review Status: FDA accepted application on July 15, 2024

Adcetris (Brentuximab Vedotin)

Developer: Pfizer
Modality: ADC
PDUFA Date: March 2025
Indication / Description: Cancer / New indication for CD30-targeted ADC brentuximab vedotin, used in combination with lenalidomide and rituximab for the treatment of relapsed or refractory large B-cell lymphoma (LBCL)
Review Type: Standard Review
Application Submission Time: May 2024

Review Status: FDA accepted application on July 30, 2024

Susvimo (Eye Implant Intravitreal Injection Ranibizumab)

Developer: Roche
Modality: Monoclonal Antibody
PDUFA Date: No later than March 2025
Indication/Description: Ophthalmology/new indication for ranibizumab, offering a customized VEGF inhibitor formula (different from Lucentis intravitreal injection) that lasts for up to six months, used for treating diabetic macular edema and diabetic retinopathy.
Review Type: Standard review
Application Submission Date: May 2024

Review Status: FDA accepted application on July 18, 2024

Neffy (Epinephrine 1mg Nasal Spray)

Developer: ARS Pharmaceuticals
Modality: Small Molecule
PDUFA Date: March 6, 2025
Indication/Description: Immunology/new concentration of 1mg and expanded pediatric indication for nasal emergency treatment of type 1 allergic reactions (including anaphylactic shock) in children weighing 15-30 kg.
Review Type: Priority review; 505(b)(2) NDA

Application Submission Date: September 9, 2024

Furoscix (Furosemide, Subcutaneous Formulation)

Developer: scPharmaceuticals
Modality: Small Molecule
PDUFA Date: March 6, 2025
Indication/Description: Cardiovascular Disease/new indication, subcutaneous injection for treating edema caused by fluid overload in chronic kidney disease (CKD) patients.
Review Type: Standard review
Application Submission Date: May 2024

Review Status: FDA accepted application on July 25, 2024

CT-P39 (Omalizumab Biosimilar)

Developer: Celltrion
Modality: Monoclonal Antibody
PDUFA Date: No later than March 11, 2025
Indication/Description: Immunology/biosimilar of Genentech's Xolair for treating severe persistent allergic asthma, nasal polyps, urticaria, and IgE-mediated food allergies.
Review Type: Standard review; 351(k) BLA

Application Submission Date: March 11, 2024

Condoliase (SI-6603, New Biologic)

Developer: Seikagaku/Ferring Pharmaceutical
Modality: Protein
PDUFA Date: No later than March 14, 2025
Indication/Description: CNS Disease/treatment for radicular leg pain associated with adult lumbar disc herniation (LDH).
Review Type: Standard review
Application Submission Date: March 2024

Review Status: FDA accepted application on May 14, 2024, Advisory Committee meeting on January 1, 2025

Revakinagene Taroretcel (NT-501, New Biologic)

Developer: Neurotech Pharmaceuticals
Modality: Gene Therapy
PDUFA Date: March 18, 2025
Indication/Description: Ophthalmology/treatment for type 2 macular telangiectasia (MacTel), a condition affecting macular capillaries.
Review Type: Priority review
Application Submission Date: April 2024

Review Status: FDA accepted application on June 20, 2024, PDUFA date delayed from original December 17, 2024.

Camrelizumab (SHR-1210, New Biologic)

Developer: Jiangsu Hengrui (licensed to Elevar in October 2023)
Modality: Monoclonal Antibody
PDUFA Date: March 20, 2025
Indication/Description: Cancer/PD-1 inhibitor combined with Elevar’s VEGFR-2 kinase inhibitor, Rivoceranib, for first-line systemic treatment of unresectable or metastatic hepatocellular carcinoma (uHCC).
Review Type: Standard review
Application Submission Date: September 23, 2024

Review Status: First BLA submission on May 17, 2023, FDA issued Complete Response Letter on May 27, 2024, second application accepted.

Amvuttra (Vutrisiran)

Developer: Alnylam
Modality: Oligonucleotide
PDUFA Date: March 23, 2025
Indication/Description: Cardiovascular/CNS Disease/new indication for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) with associated cardiomyopathy.
Review Type: Using Priority Review Voucher (PRV)
Application Submission Date: October 9, 2024

Review Status: FDA accepted application on November 25, 2024.

Rivoceranib (New Molecular Entity)

Developer: Elevar Therapeutics (HLB LifeScience)
Modality: Small Molecule
PDUFA Date: No later than March 23, 2025
Indication/Description: Cancer/combined with Hengrui's PD-1 inhibitor Camrelizumab for first-line treatment of unresectable hepatocellular carcinoma (uHCC).
Review Type: Standard review
Application Submission Date: September 23, 2024

Review Status: NDA submission rejected on May 17, 2023, second submission accepted.

TLX007-CDx

Developer: Telix
Modality: Radioactive Tracer
PDUFA Date: March 24, 2025
Indication/Description: Cancer Imaging Agent/Prostate cancer diagnosis.
Review Type: Standard review
Application Submission Date: May 27, 2024

Review Status: FDA accepted application on July 24, 2024.

Gepotidacin (New Molecular Entity)

Developer: GSK
Modality: Small Molecule
PDUFA Date: March 26, 2025
Indication/Description: Infectious Disease/oral treatment for uncomplicated urinary tract infections (uUTI) in adult women (≥40 kg) and adolescents (≥12 years, ≥40 kg).
Review Type: Priority review
Application Submission Date: July 2024

Review Status: FDA accepted application on October 16, 2024.

Cardamyst (Etripamil, New Molecular Entity)

Developer: Milestone Pharmaceuticals
Modality: Small Molecule
PDUFA Date: March 26, 2025
Indication/Description: Cardiovascular/nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT).
Review Type: Standard review
Application Submission Date: March 28, 2024

Review Status: FDA issued RTF letter in December 2023, resubmission accepted on May 26, 2024.

Egrifta MDV (Tesamorelin F8 Formulation)

Developer: Theratechnologies
Modality: Peptide
PDUFA Date: No later than March 26, 2025
Indication/Description: Metabolic Disease/for treating HIV-associated lipodystrophy.
Review Type: Standard review
Application Submission Date: November 26, 2024

Review Status: FDA accepted following a complete response letter.

DCCR (Diazoxide Choline)

Developer: Soleno Therapeutics
Modality: Small Molecule
PDUFA Date: March 27, 2025
Indication/Description: Endocrine Disease/for treatment of Prader-Willi syndrome (PWS) in patients aged 4 years and older.
Review Type: Priority review
Application Submission Date: June 27, 2024

Review Status: PDUFA date initially set for December 27, 2024, later extended.

Fitusiran (New Molecular Entity)

Developer: Sanofi
Modality: Oligonucleotide
PDUFA Date: March 28, 2025
Indication/Description: Hematology/for adult and adolescent patients with hemophilia A or B.
Review Type: Standard review
Application Submission Date: March 2024

Review Status: Breakthrough Therapy designation for Hemophilia B treatment.

Darzalex Faspro (Daratumumab/Hyaluronidase-fihj)

Developer: Johnson & Johnson/Genmab
Modality: Antibody/Enzyme
PDUFA Date: No later than March 30, 2025
Indication/Description: Cancer/using Halozyme's Enhanze technology for subcutaneous daratumumab to treat newly diagnosed multiple myeloma (NDMM) in adults.
Review Type: Priority review

Application Submission Date: September 30, 2024

Sepiapterin (PTC923, Originally known as CNSA-001, New Molecular Entity)

Developer: PTC Therapeutics
Modality: Small Molecule
PDUFA Date: No later than March 30, 2025
Indication/Description: Congenital Defects/for the treatment of phenylketonuria (PKU) in children and adults, across all age groups and disease subtypes.
Review Type: Standard review
Application Submission Date: July 30, 2024

Review Status: FDA accepted application on October 1, 2024.

Jynneos (Smallpox/Monkeypox Vaccine)

Developer: Bavarian Nordic
Modality: Vaccine
PDUFA Date: No later than March 31, 2025
Indication/Description: Infectious Disease/new freeze-dried, non-replicating vaccine formulation based on attenuated live vaccinia virus, suitable for long-term storage, for preventing smallpox and monkeypox in adults 18 years and older.
Review Type: Standard review

Application Submission Date: May 31, 2024

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