Why is "New Drug Application" trending?
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Trend Analysis
- Ranking position: #
- Date: 2026-03-22 18:16:12
This topic has appeared in the trending rankings 1 time(s) in the past year. While it does not trend frequently, its appearance suggests a renewed or concentrated surge of public interest.
Based on Wikipedia pageviews and search interest, this topic gained significant attention on the selected date.
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Wikipedia Overview
The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful.
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Trending Topic Today
Search Interest Perspective
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IntraBio Submits Supplemental New Drug Application for Levacetylleucine to Treat Ataxia-Telangiectasia - Neurology Live
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IntraBio Announces Submission of Supplemental New Drug Application for Levacetylleucine for Ataxia-Telangiectasia - Business Wire
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PolyPid Receives PDUFA Fee Waiver from FDA for D-PLEX₁₀₀’s New Drug Application - Yahoo Finance
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FDA Accepts Viatris Supplemental New Drug Application for MR-141 (Phentolamine Ophthalmic Solution 0.75%) for the Treatment of Presbyopia - PR Newswire
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$4.3M FDA fee waived for new drug to prevent surgical infections - Stock Titan
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Cogent Biosciences Announces FDA Acceptance Of New Drug Application For Bezuclastinib In Patients With Nonadvanced Systemic Mastocytosis (Nonadvsm) - TradingView
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NRx Pharmaceuticals (Nasdaq:NRXP) Confirms Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine) Following Type C FDA Meeting - Sahm
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FDA Accepts New Drug Application for BTK Inhibitor Tirabrutinib - Targeted Oncology
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Baxdrostat New Drug Application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension - AstraZeneca
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Cogent Biosciences Announces FDA Acceptance of New Drug Application for Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) - ChartMill
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FDA Accepts Investigational New Drug Application for COMP360 for PTSD - Psychiatric Times
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FDA clears Novaliq’s Investigational New Drug application for NOV05 - Ophthalmology Times
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FDA Accepts New Drug Application for Pimicotinib for TGCT - News - EMD Serono
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FDA sets Dec. 30 action date on new nonadvanced systemic mastocytosis drug - Stock Titan
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FDA Accepts New Drug Application for Orexin Agonist Oveporexton in Narcolepsy Type 1, Grants Priority Review - Neurology Live
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FDA Accepts New Drug Application for Giredestrant in Advanced Breast Cancer - Targeted Oncology
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Cogent Biosciences Announces FDA Acceptance of New Drug Application for Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) - Yahoo Finance
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FDA lets ketamine depression drug seek approval without new trials - Stock Titan
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Dry eye drug’s fast-acting promise stalls as FDA questions trial results - Stock Titan
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TuHURA Files Investigational New Drug Application for TBS-2025 in the Treatment of Blood-Related Cancers - PR Newswire
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Investigational New Drug Application filed for TBS-2025; Drug to be Investigated in Combination with a Menin Inhibitor in mutNPM1 r/r AML - Onco'Zine
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Priovant Announces FDA Acceptance and Priority Review of New Drug Application for Brepocitinib in Dermatomyositis - Yahoo Finance
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FDA Issues Complete Response Letter for Biohaven's VYGLXIA (troriluzole) New Drug Application for Spinocerebellar Ataxia - PR Newswire
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Opus Genetics Announces FDA Acceptance of Supplemental New Drug Application for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia - Yahoo Finance
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FDA Accepts New Drug Application for Tau PET Imaging Agent MK-6240 in Alzheimer Disease - Neurology Live
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Beren Therapeutics Announces FDA Acceptance of its New Drug Application for Adrabetadex in Infantile-Onset Niemann-Pick Disease Type C - BioSpace
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China’s NMPA Accepts New Drug Application for Tinengotinib Tablets for Advanced Cholangiocarcinoma - OncLive
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FDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer - BioSpace
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Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics Initiate Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Zipalertinib for Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGF - PR Newswire
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Sebela Pharmaceuticals® Announces Submission of New Drug Application to FDA for Tegoprazan for the Treatment of Gastroesophageal Reflux Disease - PR Newswire
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FDA Clears Investigational New Drug Application for TNX-102 SL for Treatment of Major Depressive Disorder - Psychiatric Times
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Bayer Contrast Agent New Drug Application Accepted for FDA Review - Imaging Technology News
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FDA Accepts New Drug Application for 177Lu-Edotreotide in GEP-NETs - CancerNetwork
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U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults - Yahoo Finance
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STEALTH BIOTHERAPEUTICS RESUBMITS NEW DRUG APPLICATION FOR ELAMIPRETIDE FOR THE TREATMENT OF BARTH SYNDROME - PR Newswire
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Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib for the Treatment of TKI Pre-treated Patients with Advanced ROS1-positive NSCLC - PR Newswire
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HBM Holdings Says NMPA Approved Investigational New Drug Application For HBM7575 (SKB575) For Atopic Dermatitis - TradingView
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FDA Accepts New Drug Application for Gedatolisib in PIK3CA Wild-Type Breast Cancer - CancerNetwork
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U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Iberdomide in Patients with Relapsed or Refractory Multiple Myeloma - Business Wire
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Priovant Announces FDA Acceptance And Priority Review Of New Drug Application For Brepocitinib In Dermatomyositis - TradingView
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Axsome to Submit New Drug Application for Narcolepsy Treatment AXS-12 - Sleep Review
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AbbVie Submits New Drug Application to U.S. FDA for Tavapadon for the Treatment of Parkinson's Disease - PR Newswire
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Supplemental New Drug Application Submitted for AXS-05 as Treatment for Alzheimer Disease Agitation - Neurology Live
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Chinese NMPA Accepts New Drug Application for Illuccix for Prostate Cancer Imaging - Yahoo Finance
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Exelixis Announces U.S. FDA Accepted the New Drug Application for Zanzalintinib in Combination with an Immune Checkpoint Inhibitor for Patients with Metastatic Colorectal Cancer - Business Wire
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Gadoquatrane New Drug Application Accepted for Review by U.S. FDA - Bayer
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FDA Accepts New Drug Application for Cytisinicline for Smoking Cessation - Psychiatric Times
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GSK to Submit Supplemental New Drug Application Updating Label for Leucovorin - Pharmaceutical Executive
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Planned FDA Investigational New Drug Application: SPC-15 for the Treatment of PTSD - Psychiatric Times
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U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1 - Business Wire
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Kelun-Biotech's New Drug Application for Its Novel Next-generation Selective RET Inhibitor A400/EP0031 Accepted for Review by the NMPA for the Treatment of RET-fusion positive NSCLC - PR Newswire
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MAXONA PHARMACEUTICALS SUBMITS INVESTIGATIONAL NEW DRUG APPLICATION TO THE U.S. FOOD AND DRUG ADMINISTRATION FOR MAX-001 - PR Newswire
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Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission - Yahoo Finance
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Prelude Therapeutics Receives FDA Clearance of Investigational New Drug Application (IND) for PRT12396, a Mutant-selective JAK2V617F Inhibitor - Yahoo Finance
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Otsuka Announces FDA Acceptance and Priority Review of New Drug Application for Centanafadine for the Treatment of ADHD in Children, Adolescents, and Adults - BioSpace
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Otsuka Pharmaceutical Submits New Drug Application to U.S. FDA for Centanafadine for the Treatment of ADHD in Children, Adolescents, and Adults - BioSpace
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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 - Yahoo Finance
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BioXcel Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for IGALMI® Label Expansion in the At-Home Setting - Yahoo Finance
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Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance for Filing of New Drug Application for Tirabrutinib in Patients with Relapsed or Refractory PCNSL - Business Wire
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BRIEF: Everest Medicines advances with major licensing deal, new drug application approval - thebambooworks.com
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FDA grants priority review to new injection for blood disorder polycythemia vera - Stock Titan
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Nicox Completes NCX 470 New Drug Application Key Data Generation for Submission as Planned in H1 2026 - GlobeNewswire
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Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer - Yahoo Finance
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Celcuity Announces FDA Acceptance of New Drug Application - GlobeNewswire
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Cogent Biosciences to Initiate New Drug Application - GlobeNewswire
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FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer - GlobeNewswire
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Discovery, Abbreviated New Drug Application (ANDA), Delaware - JD Supra
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Organon Announces US Food and Drug Administration Approval of Supplemental New Drug Application Extending Duration of Use of NEXPLANON® (etonogestrel implant) 68 mg Radiopaque - Yahoo Finance
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Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in NonAdvanced Systemic Mastocytosis - Yahoo Finance
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NRx Pharmaceuticals Announces Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 Following Type C FDA Meeting - Investing News Network
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FDA Accepts New Drug Application for Relacorilant in Ovarian Cancer - Cure Today
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FDA accepts supplemental New Drug Application for Pharming’s paediatric immunodeficiency therapy - PMLiVE
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Precision BioSciences Receives U.S. FDA Clearance of Investigational New Drug Application for First-in-Class PBGENE-DMD for Treatment of Duchenne Muscular Dystrophy - Business Wire
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Nuance Pharma Announces Acceptance for Review of the New Drug Application for Ohtuvayre® (ensifentrine) by the National Medical Products Administration of China for the maintenance treatment of chronic obstructive pulmonary disease - Yahoo Finance
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FDA accepts new drug application for zoliflodacin for uncomplicated gonorrhea - Urology Times
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FDA Approved Camcevi ETM New Drug Application for Prostate Cancer - Cure Today
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FDA Accepts New Drug Application for Merck’s HIV Treatment, Doravirine/Islatravir - Contagion Live
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Biofrontera Announces FDA Filing Acceptance of Supplemental New Drug Application for Ameluz® PDT in Superficial Basal Cell Carcinoma - Yahoo Finance
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Emergent BioSolutions Receives U.S. FDA Approval of Supplemental New Drug Application (sNDA) for NARCAN® Nasal Spray Multipacks - Yahoo Finance
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FDA accepts New Drug Application for Merck’s HIV investigational treatment regimen doravirine/islatravir - European AIDS Treatment Group
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FDA Accepts Arvinas’s New Drug Application for Advanced Breast Cancer Treatment - The Clinical Trial Vanguard
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Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer’s Disease in Japan - Yahoo Finance
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Kelun-Biotech's New Drug Application for Its Novel Next-generation Selective RET Inhibitor A400/EP0031 Accepted for Review by the NMPA for the Treatment of RET-fusion positive NSCLC - Colorado Springs Gazette
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LENZ Therapeutics Announces NMPA Submission of New Drug Application for LNZ100 in China for the Treatment of Presbyopia - LENZ Therapeutics
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Berman Tabacco Announces Investigation of Corcept - GlobeNewswire
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FDA accepts for review Aldeyra Therapeutics’ resubmitted New Drug Application for reproxalap - Ophthalmology Times
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Eisai submits new drug application for subcutaneous Leqembi in Japan - PMLiVE
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Elevar Therapeutics Submits New Drug Application to FDA for - GlobeNewswire
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Beren, Through its Subsidiary Mandos, Submits New Drug Application to U.S. FDA for Adrabetadex in Infantile-Onset NPC - Business Wire
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FDA Accepts a New Drug Application From Rhythm Pharmaceuticals (RYTM) - Yahoo Finance
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FDA approves abbreviated new drug application from Amneal Pharmaceuticals for bimatoprost ophthalmic solution 0.01% - Ophthalmology Times
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Recludix Pharma Announces FDA Clearance of Investigational New Drug Application for REX-8756, an Oral STAT6 Inhibitor, to Enter into the Clinic - Yahoo Finance
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FDA Accepts Cingulate’s New Drug Application for CTx-1301 - GlobeNewswire
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ITM Announces FDA Acceptance of New Drug Application (NDA) - GlobeNewswire
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LENZ Therapeutics Announces MFDS Submission of New Drug Application for LNZ100 (VIZZ™) in South Korea for the Treatment of Presbyopia - Yahoo Finance
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FDA Accepts Gadoquatrane New Drug Application - Contract Pharma
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Teva Pharmaceuticals Submits New Drug Application to FDA - GlobeNewswire
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MannKind Announces U.S. FDA Accepts for Review its Supplemental New Drug Application (sNDA) of FUROSCIX ReadyFlow™ Autoinjector for the Treatment of Edema in Adults with Chronic Heart Failure or Chronic Kidney Disease - Yahoo Finance
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Teva Pharmaceuticals Submits New Drug Application for Olanzapine Long-Acting Injectable for Schizophrenia Treatment - Quiver Quantitative
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The New Drug Application for KN026 (Anbenitamab Injection) Has Been Accepted by the National Medical Products Administration - Yahoo Finance
Why This Topic Is Trending
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