New Drug Applications Archive for 2021
January 4, 2021
- Provention Bio Announces U.S. FDA Filing of a Biologics License Application (BLA) and Priority Review for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-risk Individuals
- US FDA Accepts Regulatory Submission from Pfizer and OPKO for Review of Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency
January 5, 2021
January 19, 2021
January 20, 2021
January 25, 2021
- Albireo Announces U.S. FDA Acceptance of New Drug Application for Odevixibat
- Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem
January 29, 2021
February 1, 2021
February 8, 2021
February 10, 2021
February 16, 2021
February 19, 2021
February 22, 2021
- Noven Submits New Drug Application for Investigational Dextroamphetamine Transdermal System for ADHD
February 25, 2021
- Allergan Submits New Drug Application for Investigational AGN-190584 for the Treatment of Presbyopia
March 1, 2021
- Avadel Pharmaceuticals Announces FDA Acceptance of New Drug Application for FT218 in Adults with Narcolepsy for the Treatment of Excessive Daytime Sleepiness and Cataplexy
- Reata Pharmaceuticals, Inc. Submits NDA for Company’s Lead Program: Bardoxolone in Alport Syndrome
- U.S. FDA Accepts Merck’s Gefapixant New Drug Application for Review
March 2, 2021
- Eyenovia Announces FDA Acceptance of the MydCombi NDA
- Strongbridge Biopharma plc Announces Submission of New Drug Application for Recorlev (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome to the FDA
- Oyster Point Pharma Announces FDA Acceptance for Filing New Drug Application for OC-01 (varenicline) Nasal Spray for the Treatment of Signs and Symptoms of Dry Eye Disease
March 8, 2021
March 10, 2021
- Kadmon Announces U.S. FDA Has Extended the Review Period for Belumosudil in Chronic Graft-Versus-Host Disease
- FDA Accepts the New Drug Application for Review of Idorsia’s Daridorexant for the Treatment of Adult Patients with Insomnia
March 11, 2021
- Marius Pharmaceuticals Receives PDUFA Date for Kyzatrex NDA for Treatment of Hypogonadism
- BioXcel Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders
March 15, 2021
March 16, 2021
March 19, 2021
March 25, 2021
March 28, 2021
March 29, 2021
- TG Therapeutics Completes Rolling Submission of Biologics License Application to the U.S. Food and Drug Administration for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia
- Mirum Pharmaceuticals Announces FDA Acceptance of New Drug Application and Priority Review for Maralixibat in Alagille Syndrome
March 30, 2021
- U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine
- Akebia Submits New Drug Application (NDA) to the FDA for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis
March 31, 2021
- Evive Biotech Submits Biologics License Application to US FDA for Ryzneuta
- CTI BioPharma Announces Completion of Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia
April 7, 2021
April 9, 2021
April 26, 2021
- Axsome Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for AXS-05 for Treatment of Major Depressive Disorder
- Reata Announces FDA Accepted for Filing the NDA for Bardoxolone for the Treatment of Patients With Chronic Kidney Disease Caused by Alport Syndrome
April 27, 2021
May 3, 2021
May 10, 2021
- Liquidia Resubmits New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension
- Amgen Announces Tezepelumab Biologics License Application Submitted To U.S. FDA
May 13, 2021
May 17, 2021
May 18, 2021
May 19, 2021
May 20, 2021
May 25, 2021
May 28, 2021
- Fennec Pharmaceuticals Resubmits New Drug Application To U.S. Food And Drug Administration For Pedmark
- Verrica Pharmaceuticals Announces Extension of FDA Review Period of its NDA for VP-102 for the Treatment of Molluscum Contagiosum
- Ipsen Confirms U.S. FDA Accepts New Drug Application for Palovarotene as the First Potential Treatment Worldwide for Fibrodysplasia Ossificans Progressiva (FOP)
June 1, 2021
- Mycovia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis
- Akebia and Otsuka Announce FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis
- CTI BioPharma Announces Acceptance of NDA Granted with Priority Review of Pacritinib for Treatment of Patients with Myelofibrosis
- BeyondSpring Announces U.S. FDA Acceptance And Priority Review Of New Drug Application For Plinabulin And G-CSF Combination For The Prevention Of Chemotherapy-Induced Neutropenia (CIN)
June 3, 2021
June 9, 2021
June 11, 2021
June 18, 2021
June 21, 2021
June 22, 2021
June 24, 2021
- Alnylam Announces U.S. Food and Drug Administration Acceptance of New Drug Application for Investigational Vutrisiran for the Treatment of the Polyneuropathy of Hereditary ATTR Amyloidosis
- Aquestive Therapeutics Resubmits New Drug Application for Libervant (diazepam) Buccal Film
June 28, 2021
July 1, 2021
July 6, 2021
- Provention Bio Receives Complete Response Letter (CRL) to Biologics License Application (BLA) for Teplizumab for the Delay of Clinical Type 1 Diabetes (T1D) in At-Risk Individuals
- FDA Grants Priority Review for Levo Therapeutics’ New Drug Application for LV-101 (Intranasal Carbetocin) for the Treatment of Prader-Willi Syndrome
July 7, 2021
July 16, 2021
July 19, 2021
- Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film
- Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
July 26, 2021
July 27, 2021
July 28, 2021
- Mycovia Pharmaceuticals Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis
- FDA Accepts Application for Genentech’s Faricimab for the Treatment of Wet Age-Related Macular Degeneration (AMD) and Diabetic Macular Edema (DME)
July 29, 2021
August 2, 2021
August 3, 2021
August 6, 2021
August 9, 2021
August 10, 2021
August 11, 2021
August 13, 2021
- Ipsen Announces Withdrawal of Palovarotene NDA, Confirming Intention to Resubmit Following Additional Data Analyses
- Sesen Bio Receives Complete Response Letter from FDA for Vicineum (oportuzumab monatox-qqrs)
August 17, 2021
August 23, 2021
August 24, 2021
August 25, 2021
- Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of Comirnaty in Individuals 16 and Older
- Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine
September 1, 2021
September 14, 2021
September 15, 2021
September 20, 2021
- Verrica Pharmaceuticals Receives Complete Response Letter from the FDA identifying deficiencies at a facility of a Contract Manufacturer for its New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
- U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination as Treatment for Patients with Unresectable or Metastatic Melanoma
- Marinus Pharmaceuticals Announces FDA Acceptance for Filing and Priority Review of New Drug Application for Ganaxolone in CDKL5 Deficiency Disorder
September 24, 2021
September 27, 2021
September 28, 2021
October 1, 2021
October 4, 2021
October 18, 2021
October 28, 2021
November 1, 2021
- Hyloris Announces FDA Acceptance of New Drug Application for Maxigesic IV in Post-Operative Pain
- Incyte Announces Acceptance of NDA for Parsaclisib for Three Types of Relapsed or Refractory Non-Hodgkin Lymphomas
November 2, 2021
November 8, 2021
November 18, 2021
November 19, 2021
November 22, 2021
November 23, 2021
November 29, 2021
- Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
- Fennec Pharmaceuticals Expects to Receive Complete Response Letter from the FDA for its New Drug Application for Pedmark™ to Prevent Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors
November 30, 2021
December 1, 2021
December 3, 2021
December 6, 2021
December 8, 2021
December 15, 2021
December 16, 2021
December 20, 2021
December 21, 2021
December 22, 2021
- Allarity Therapeutics Submits New Drug Application (NDA) to the U.S. FDA for Dovitinib for Third-Line Treatment of Renal Cell Carcinoma (RCC)
- FDA Accepts Arcutis Biotherapeutics’ New Drug Application for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis
December 29, 2021
December 30, 2021
New drug applications archive
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.