Ozempic (semaglutide)

Developer: Novo Nordisk
Modality: Peptide
PDUFA Date: January 2025
Indication/Description: Metabolic, Renal / A new indication for once-weekly subcutaneous semaglutide to treat adults with type 2 diabetes and chronic kidney disease (CKD), including delaying CKD progression and reducing the risk of kidney and cardiovascular death.
Review Type: Standard Review
Submission Date: March 2024

Review Status: FDA accepted the application on June 24, 2024.

Subvenite (lamotrigine oral liquid)

Developer: OWP Pharmaceuticals
Modality: Small molecule
PDUFA Date: January 3, 2025
Indication/Description: Central Nervous System Disorders / A new oral liquid formulation of the antiepileptic drug lamotrigine for the treatment of epilepsy and bipolar disorder.
Review Type: 505(b)(2) NDA, Standard Review
Submission Date: March 2024

Review Status: FDA accepted the application on May 20, 2024.

TX05 (trastuzumab biosimilar)

Developer: Tanvex
Modality: Monoclonal antibody
PDUFA Date: No later than January 6, 2025
Indication/Description: Cancer / A biosimilar to Genentech's HER2-targeted antibody Herceptin.
Review Type: 351(k) BLA, Standard Review
Submission Date: July 6, 2024 (Resubmission)

Review Status: FDA previously issued a complete response letter in August 2022.

Ryoncil (remestemcel-L-rknd, new biological product)

Developer: Mesoblast
Modality: Cell therapy
PDUFA Date: January 7, 2025
Indication/Description: Immunology / Allogeneic expanded mesenchymal stromal cell (MSC) therapy for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients.
Review Type: Priority Review
Submission Date: July 8, 2024 (Resubmission)

Review Status: FDA previously issued a second complete response letter on August 3, 2022 (first issued on October 1, 2020).

Tabelecleucel (new biological product)

Developer: Atara Biotherapeutics / Pierre Fabre
Modality: Cell therapy
PDUFA Date: January 15, 2025
Indication/Description: Immunology, Supportive therapy / Allogeneic Epstein-Barr virus (EBV)-specific T cell immunotherapy for the monotherapy treatment of EBV-positive post-transplant lymphoproliferative disorder (EBV+ PTLD) in patients aged 2 years and older who have received at least one prior therapy.
Review Type: Priority Review
Submission Date: May 20, 2024

Review Status: Breakthrough Therapy designation.

Lumakras (sotorasib)

Developer: Amgen
Modality: Small molecule
PDUFA Date: January 17, 2025
Indication/Description: Cancer / A new indication for treatment of KRAS G12C-mutant metastatic colorectal cancer (CRC) in combination with panitumumab (Vectibix).
Review Type: Priority Review
Submission Date: April 2024

Review Status: Delayed, original PDUFA date was October 17, 2024.

Leqembi (lecanemab-irmb)

Developer: Eisai / Biogen
Modality: Antibody
PDUFA Date: January 25, 2025
Indication/Description: Central Nervous System Diseases / A new maintenance dosing regimen for patients who have completed the initial bi-weekly phase of Alzheimer's disease treatment, providing monthly intravenous Leqembi injections.
Review Type: Standard Review
Submission Date: April 1, 2024

Review Status: FDA accepted the application on June 9, 2024.

CT-P47 (tocilizumab biosimilar)

Developer: Celltrion
Modality: Monoclonal antibody
PDUFA Date: No later than January 28, 2025
Indication/Description: Immunology / A biosimilar to Actemra (tocilizumab) for rheumatoid arthritis and juvenile idiopathic arthritis.
Review Type: 351(k) BLA, Standard Review

Submission Date: January 28, 2024

Elamipretide (New Molecular Entity)

Developer: Stealth BioTherapeutics
Modality: Peptide
PDUFA Date: January 29, 2025
Indication/Description: Cardiovascular congenital diseases / Mitochondrial protective peptide bound to cardiolipin, for treating Barth syndrome
Review Type: Priority Review (Initially Standard Review, changed to Priority Review at the request of Stealth Bio)
Submission Date: January 2024

Review Status: Initial submission in August 2021, FDA issued a Refuse to File (RTF) letter in October 2021; resubmission accepted by FDA on April 8, 2024; designated as a rare pediatric disease.

Suzetrigine (VX-548, New Molecular Entity)

Developer: Vertex
Modality: Small Molecule
PDUFA Date: January 30, 2025
Indication/Description: Central nervous system disorders / Selective NaV1.8 pain signal inhibitor, oral, non-opioid medication for treating moderate to severe acute pain
Review Type: Priority Review
Submission Date: May 30, 2024

Review Status: FDA accepted the application on July 30, 2024; designated as a breakthrough therapy

Treosulfan (New Drug)

Developer: medac GmbH/Medexus
Modality: Small Molecule
PDUFA Date: January 30, 2025
Indication/Description: Cancer, hematologic diseases / Bifunctional alkylating agent, used with fludarabine as a reduced toxicity conditioning regimen for adult and pediatric patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT)
Review Type: Standard Review
Submission Date: April 2024
Review Status: FDA issued a complete response letter on August 3, 2021; resubmitted and accepted by FDA on June 6, 2024; PDUFA date delayed from the initial October 30, 2024.

AXS-07 (Meloxicam/Rizatriptan)

Developer: Axsome Therapeutics
Modality: Small Molecule
PDUFA Date: January 31, 2025
Indication/Description: Central nervous system disorders / Acute treatment of migraines
Review Type: 505(b)(2) NDA Standard Review
Submission Date: July 2024

Review Status: First submitted in July 2021, FDA issued a complete response letter on May 2, 2022; resubmitted and accepted by FDA on September 4, 2024.

Translarna (Ataluren, New Molecular Entity)

Developer: PTC Therapeutics
Modality: Small Molecule
PDUFA Date: February or March 2025
Indication/Description: Central nervous system disorders / Treatment for Duchenne muscular dystrophy (nmDMD) with nonsense mutations
Review Type: Priority Review

Submission Date: August to September 2024

Omvoh (Mirikizumab-MRKZ)

Developer: Eli Lilly
Modality: Monoclonal Antibody
PDUFA Date: No later than February 2025
Indication/Description: Gastrointestinal diseases / New indication for Omvoh, for treating moderate to severe active Crohn's disease in adults
Review Type: Standard Review

Submission Date: March to April 2024

Enhertu (Fam-Trastuzumab Deruxtecan-NXKI)

Developer: Daiichi Sankyo/AstraZeneca
Modality: ADC (Antibody-Drug Conjugate)
PDUFA Date: February 1, 2025
Indication/Description: Cancer / New indication for Enhertu, for treating unresectable or metastatic HER2-low or HER2 ultra-low breast cancer in adults
Review Type: Priority Review
Submission Date: August 1, 2024

Review Status: FDA accepted the application on October 1, 2024; designated as a breakthrough therapy

SPN-830 (Apomorphine Infusion Pump)

Developer: Supernus/US WorldMeds/Brittania
Modality: Small Molecule
PDUFA Date: February 1, 2025
Indication/Description: Central nervous system disorders / Continuous subcutaneous infusion of the dopamine agonist apomorphine, used to treat motor fluctuations (OFF episodes) in adult Parkinson's disease patients
Review Type: Standard Review
Submission Date: August 1, 2024

Review Status: Experienced one RTF (Refuse to File) and two complete response letters.

Bentracimab (New Biological Product)

Developer: SFJ Pharmaceuticals / SERB Pharmaceuticals
Modality: Antibody
PDUFA Date: Not later than February 2, 2025
Indication / Description: Cardiovascular Disease / For emergency bleeding events caused by ticagrelor, or reversal of ticagrelor’s antiplatelet effect in emergency surgery situations
Review Type: Priority Review
Application Submission Time: May to June 2024

Review Status: FDA accepted BLA submission on August 2, 2024; Breakthrough Therapy Designation

Datopotamab Deruxtecan (Dato-DXd, New Biological Product)

Developer: Daiichi Sankyo / AstraZeneca
Modality: ADC
PDUFA Date: Not later than February 2, 2025
Indication / Description: Cancer / For adult patients with metastatic hormone receptor-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer
Review Type: Standard Review
Application Submission Time: January to February 2024

Review Status: FDA accepted BLA submission on April 2, 2024

Sublocade (Buprenorphine Depot Injection)

Developer: Indivior
Modality: Small Molecule
PDUFA Date: February 7, 2025
Indication / Description: Central Nervous System Diseases / Subcutaneous opioid agonist for the treatment of moderate-to-severe opioid use disorder (OUD)
Review Type: Priority Review
Application Submission Time: August 2024

Review Status: FDA accepted application on October 7, 2024

Rexulti (Brexpiprazole)

Developer: Otsuka / Lundbeck
Modality: Small Molecule
PDUFA Date: February 8, 2025
Indication / Description: Central Nervous System Diseases / A serotonin-dopamine activity modulator (SDAM) atypical antipsychotic, for use with sertraline for treating adult post-traumatic stress disorder (PTSD)
Review Type: Standard Review
Application Submission Time: April 10, 2024

Review Status: FDA accepted application on June 25, 2024

CHIKV VLP (Chikungunya Vaccine, Previously PXVX0317, New Biological Product)

Developer: Bavarian Nordic
Modality: Vaccine
PDUFA Date: February 14, 2025
Indication / Description: Infectious Disease / For the prevention of chikungunya virus infection in adults and children 12 years and older
Review Type: Priority Review
Application Submission Time: June 17, 2024

Review Status: Breakthrough Therapy Designation

MenABCWY (Meningococcal Group A, B, C, Y/W-135 Vaccine, New Biological Product)

Developer: GSK
Modality: Vaccine
PDUFA Date: February 14, 2025
Indication / Description: Infectious Disease / For the prevention of invasive meningococcal disease
Review Type: Standard Review
Application Submission Time: February 2024

Review Status: FDA accepted application on April 16, 2024

Continue to read about FDA 2025 Q1 Approval Overview (II) >>>