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 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