New Drug Applications Archive for 2024

January 5, 2024

• Journey Medical Corporation Submits New Drug Application to FDA for DFD-29 to Treat Rosacea

January 8, 2024

• Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.
• FDA Grants Soligenix Fast Track Designation for Dusquetide in the Treatment of Oral Lesions of Behçet's Disease

January 18, 2024

• FDA Issues Complete Response Letter for Satsuma’s STS101

January 24, 2024

• UroGen Initiates Submission of a Rolling NDA to the FDA for UGN-102

January 25, 2024

• Liquidia Corporation Provides Update on New Drug Application for Yutrepia (treprostinil) inhalation powder

January 30, 2024

• Defender Pharmaceuticals Receives Complete Response Letter from the U.S. Food and Drug Administration for its Intranasal Scopolamine (DPI-386) New Drug Application for the Prevention of Nausea and Vomiting Induced by Motion in Adults

February 5, 2024

• Bridgebio Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application (NDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

February 8, 2024

• Amneal Announces Complete Response Resubmission for IPX203 New Drug Application

February 9, 2024

• Lykos Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSD

February 12, 2024

• FDA Accepts Xspray Pharma’s NDA-Resubmission for Dasynoc

February 13, 2024

• Citius Pharmaceuticals Resubmits the Biologics License Application of Lymphir (denileukin diftitox) for the Treatment of Adults With Relapsed or Refractory Cutaneous T-Cell Lymphoma

February 14, 2024

• Galderma Announces Regulatory Filing Acceptance for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in the U.S. and EU

February 19, 2024

• Datopotamab Deruxtecan Biologics License Application Accepted in the US for Patients with Previously Treated Advanced Nonsquamous Non-Small Cell Lung Cancer

February 20, 2024

• FDA and EMA Accept Vorasidenib Regulatory Submissions for the Treatment of IDH-mutant diffuse glioma

February 21, 2024

• Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review

February 23, 2024

• Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam

February 27, 2024

• BeiGene’s Biologics License Application for Tevimbra (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA
• Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia

February 28, 2024

• Applied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic Galactosemia

March 4, 2024

• Zevra Therapeutics Provides FDA Update On The PDUFA Action Date For Arimoclomol As A Treatment For Niemann-Pick Disease Type C
• SpringWorks Therapeutics Initiates Rolling Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN

March 6, 2024

• Lumicell Announces FDA Advisory Committee’s Positive Recommendation on the Benefit-Risk Profile of Lumisight in the Detection of Cancerous Tissue During Breast Conserving Surgery

March 13, 2024

• U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinib

March 18, 2024

• Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea

March 19, 2024

• PTC Therapeutics Announces the Submission of a BLA to the U.S. FDA for Upstaza (eladocagene exuparvovec) for the Treatment of Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency

March 25, 2024

• Regeneron Provides Update on Biologics License Application for Odronextamab

March 26, 2024

• IntraBio Announces U.S. FDA Accepts New Drug Application for IB1001 for the Treatment of Niemann-Pick Disease Type C
• Syndax Announces FDA Priority Review of NDA for Revumenib for the Treatment of Relapsed/Refractory KMT2Ar Acute Leukemia

March 28, 2024

• Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia
• Aldeyra Therapeutics Announces Clinical Development Plan for Resubmission of New Drug Application for Reproxalap in Dry Eye Disease
• Milestone Pharmaceuticals Announces Resubmission of New Drug Application for Etripamil for Treatment in Paroxysmal Supraventricular Tachycardia

April 2, 2024

• Datopotamab Deruxtecan Biologics License Application Accepted in the US for Patients with Previously Treated Metastatic HR-Positive, HER2-Negative Breast Cancer
• Jazz Pharmaceuticals Completes Zanidatamab Biologics License Application for Previously Treated HER2-Positive Metastatic Biliary Tract Cancer

April 8, 2024

• Stealth Biotherapeutics Announces FDA Acceptance of New Drug Application for Elamipretide for the Treatment of Barth Syndrome
• Supernus Provides Regulatory Update for SPN-830

April 22, 2024

• Abeona Therapeutics Provides Regulatory Update on Pz-cel

April 29, 2024

• Iterum Therapeutics Resubmits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem

April 30, 2024

• Eton Pharmaceuticals Announces Submission to FDA of New Drug Application for ET-400 (Hydrocortisone Oral Solution)

May 6, 2024

• Merus Announces U.S. FDA Acceptance and Priority Review of Biologics License Application for Zeno for the Treatment of NRG1+ NSCLC and PDAC

May 14, 2024

• Ascendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon PTH for Adults with Hypoparathyroidism
• PTC Therapeutics Announces FDA Acceptance and Priority Review of the BLA for Upstaza

May 20, 2024

• Atara Biotherapeutics Submits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA

May 24, 2024

• Verastem Oncology Announces the Initiation of a Rolling Submission of NDA to FDA Seeking Accelerated Approval of Avutometinib and Defactinib Combination for the Treatment of Adult Patients with Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer

May 29, 2024

• FDA Grants Priority Review to Roche’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation
• Milestone Pharmaceuticals Announces FDA Acceptance of New Drug Application for Cardamyst

May 30, 2024

• U.S. FDA Acknowledges Astellas' Resubmission of Biologics License Application for Zolbetuximab and Sets New Action Date

May 31, 2024

• Iterum Therapeutics Receives FDA Acceptance of Resubmission of NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections

June 18, 2024

• KalVista Submits New Drug Application to FDA for Sebetralstat as First Oral On-Demand Treatment for Hereditary Angioedema

June 21, 2024

• Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 Diabetes

June 25, 2024

• Ionis Announces Olezarsen New Drug Application Accepted for Priority Review and Enrollment in Phase 3 sHTG Program Completed
• AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa)

June 26, 2024

• Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer

July 1, 2024

• SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN

July 2, 2024

• Vertex Announces FDA Acceptance of New Drug Application for Vanzacaftor/Tezacaftor/Deutivacaftor, a Next-In-Class Triple Combination Treatment for Cystic Fibrosis

July 15, 2024

• Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-400 (Hydrocortisone Oral Solution)

July 16, 2024

• Lexicon Pharmaceuticals Receives December 20, 2024 PDUFA Goal Date for Sotagliflozin Type 1 Diabetes NDA Resubmission

July 17, 2024

• Orexo Receives a Complete Response Letter Regarding the NDA for OX124, a High-Dose Naloxone Rescue Medication in Development for Opioid Overdose
• Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease

July 26, 2024

• Xspray Pharma Shares New Information on Dasynoc, a Novel CML Treatment in Development

July 29, 2024

• Syndax Announces PDUFA Action Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia

July 30, 2024

• Vertex Announces FDA Acceptance of New Drug Application for Suzetrigine for the Treatment of Moderate-to-Severe Acute Pain

August 1, 2024

• Bayer Submits New Drug Application to U.S. FDA for Elinzanetant for the Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause

August 2, 2024

• FDA Advisory Committee Votes Favorably that the Data Support Arimoclomol as Effective Treatment for Patients with Niemann-Pick Disease Type C

August 6, 2024

• George Medicines Announces GMRx2 NDA Filing to FDA

August 9, 2024

• Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD

August 12, 2024

• LENZ Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for LNZ100 for the Treatment of Presbyopia

August 14, 2024

• UroGen Submits Completed UGN-102 NDA Seeking Approval as the First FDA-Approved Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

August 16, 2024

• U.S. Food and Drug Administration Accepts for Priority Review Deciphera’s New Drug Application for Vimseltinib for the Treatment of Patients with Tenosynovial Giant Cell Tumor (TGCT)

August 19, 2024

• U.S. FDA Grants Tentative Approval of Yutrepia (treprostinil) Inhalation Powder for Patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)

August 20, 2024

• Regeneron Provides Update on Biologics License Application for Linvoseltamab

August 27, 2024

• Soleno Therapeutics Announces U.S. FDA Acceptance for Filing and Priority Review of NDA for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome

August 28, 2024

• FDA Grants Priority Review to SpringWorks Therapeutics’ New Drug Application for Mirdametinib for the Treatment of Adults and Children with NF1-PN
• Telix Submits NDA for TLX101-CDx (Pixclara) Brain Cancer Imaging Agent

August 29, 2024

• Johnson & Johnson Seeks First Approval of Nipocalimab to Treat Broadest Population Living with Antibody Positive Generalized Myasthenia Gravis

September 3, 2024

• Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
• KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema

September 4, 2024

• Axsome Therapeutics Announces FDA Acceptance of NDA Resubmission for AXS-07 for the Acute Treatment of Migraine

September 10, 2024

• Iterum Therapeutics Provides Update on FDA Advisory Committee Discussion of Oral Sulopenem for the Treatment of uUTI in Adult Women

September 18, 2024

• Applied Therapeutics Provides Regulatory Update on Govorestat for the Treatment of Classic Galactosemia

September 19, 2024

• FDA Declines to Approve Vanda's Marketing Application for Tradipitant in Gastroparesis

September 23, 2024

• FDA Accepts LEO Pharma’s Filing of Delgocitinib Cream New Drug Application for the Treatment of Chronic Hand Eczema
• Elevar Therapeutics Resubmits New Drug Application to FDA for Combination of Camrelizumab plus Rivoceranib as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma Boosted by CARES-310 Leading Overall Survival Analysis

September 27, 2024

• AbbVie Submits Biologics License Application to the FDA for Telisotuzumab Vedotin (Teliso-V) in Previously Treated Non-Small Cell Lung Cancer

October 1, 2024

• PTC Therapeutics Announces FDA Acceptance for Filing of NDA for Sepiapterin for the Treatment of Pediatric and Adult Phenylketonuria Patients

October 3, 2024

• Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye Disease

October 7, 2024

• Neuvivo Seeks FDA Approval for Its Breakthrough ALS Treatment NP001

October 9, 2024

• U.S. Food and Drug Administration (FDA) Accepts New Drug Application for Elinzanetant

October 11, 2024

• Stealth BioTherapeutics Announces Positive Vote from FDA Advisory Committee Meeting Supporting Potential Approval of Elamipretide for the Treatment of Barth Syndrome

October 15, 2024

• UroGen Announces FDA Acceptance of its New Drug Application for UGN-102

October 16, 2024

• Tonix Pharmaceuticals Announces Submission of the TNX-102 SL New Drug Application (NDA) for Fibromyalgia to the U.S. Food and Drug Administration (FDA)

October 21, 2024

• LENZ Therapeutics Announces FDA Acceptance of New Drug Application for LNZ100 for the Treatment of Presbyopia
• Elevar Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for Rivoceranib in Combination with Camrelizumab as a First-line Systemic Treatment for Unresectable Hepatocellular Carcinoma

October 22, 2024

• Camurus Provides Regulatory Update on the US NDA for CAM2029 in Acromegaly

October 24, 2024

• FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent

October 29, 2024

• Abeona Therapeutics Completes Pz-cel Biologics License Application Resubmission to U.S. Food and Drug Administration

October 30, 2024

• Satsuma Pharmaceuticals and SNBL Resubmits the New Drug Application for STS101 (Dihydroergotamine Nasal Powder) for the Acute Treatment of Migraine With or Without Aura
• PTC Therapeutics Announces FDA Acceptance of Translarna NDA Resubmission

October 31, 2024

• Verastem Oncology Completes Rolling NDA Submission to the FDA for Avutometinib Plus Defactinib as a Treatment for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer
• Lexicon Announces Outcome of FDA Advisory Committee for Zynquista (sotagliflozin) as an Adjunct to Insulin Therapy for Glycemic Control in Adults with Type 1 Diabetes and Chronic Kidney Disease

November 4, 2024

• Ionis Announces FDA Acceptance of New Drug Application for Donidalorsen for Prophylactic Treatment of HAE

November 5, 2024

• Merus Receives FDA Extension of PDUFA for Zenocutuzumab

November 8, 2024

• Dizal Submits New Drug Application to the U.S. FDA for Sunvozertinib in Treating Relapsed or Refractory Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

November 11, 2024

• Unicycive Therapeutics Announces U.S. FDA Acceptance of the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

November 12, 2024

• Datopotamab Deruxtecan New BLA Submitted for Accelerated Approval in the US for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
• Abeona Therapeutics Announces FDA Acceptance of BLA Resubmission of Pz-cel for the Treatment of Recessive Dystrophic Epidermolysis Bullosa

November 18, 2024

• Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease
• Arrowhead Pharmaceuticals Submits New Drug Application to U.S. FDA for Plozasiran for the Treatment of Familial Chylomicronemia Syndrome