New Drug Applications Archive for 2022

January 21, 2022

• Pfizer and OPKO Provide Update on the Biologics License Application for Somatrogon for Pediatric Growth Hormone Deficiency

January 25, 2022

• Incyte Provides Update on Parsaclisib and MCLA-145

January 31, 2022

• Reata Pharmaceuticals Initiates Rolling Submission of New Drug Application with U.S. FDA for Omaveloxolone for the Treatment of Patients with Friedreich’s Ataxia

February 4, 2022

• Cytokinetics Announces FDA Acceptance of New Drug Application for Omecamtiv Mecarbil for the Treatment of Heart Failure With Reduced Ejection Fraction

February 11, 2022

• Spectrum Pharmaceuticals Announces Acceptance of New Drug Application Filing for Poziotinib
• Orphazyme Provides Update for Planned NDA Resubmission for Arimoclomol for the Treatment of Niemann-Pick Disease Type C in the United States

February 15, 2022

• U.S. Food and Drug Administration (FDA) Accepts Mirati Therapeutics' New Drug Application for Adagrasib as Treatment of Previously Treated KRASG12C-Mutated Non-Small Cell Lung Cancer

February 22, 2022

• Provention Bio Announces Biologics License Application (BLA) Resubmission for Teplizumab to Address Complete Response Letter (CRL)

February 25, 2022

• Reata Pharmaceuticals Receives Complete Response Letter From The FDA for Bardoxolone for the Treatment of Patients with Chronic Kidney Disease Caused by Alport Syndrome

February 28, 2022

• Amryt Receives Complete Response Letter from the FDA for Oleogel-S10 NDA
• Lexicon Voluntarily Withdraws Sotagliflozin New Drug Application and Plans Prompt Resubmission Targeted Early Q2 2022

March 1, 2022

• Gilead Receives Complete Response Letter From U.S. FDA for Investigational Lenacapavir Due to Vial Compatibility Issues

March 3, 2022

• Nymox Announces Submission of New Drug Application (NDA) to the FDA for Fexapotide Triflutate
• TG Therapeutics Announces Extension of U.S. FDA BLA/sNDA PDUFA Date for Ublituximab Plus UKONIQ® (U2) to Treat Patients with CLL and SLL

March 14, 2022

• Phathom Pharmaceuticals Submits Vonoprazan NDA to FDA for the Treatment of Erosive Esophagitis

March 21, 2022

• Provention Bio Announces FDA Acceptance of the Biologics License Application (BLA) Resubmission for Teplizumab for the Delay of Clinical Type 1 Diabetes in At-Risk Individuals
• Travere Therapeutics Submits New Drug Application for Sparsentan for the Treatment of IgA Nephropathy

March 24, 2022

• Lilly Announces Complete Response Letter for Sintilimab in Combination with Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of People with Nonsquamous Non-Small Cell Lung Cancer
• Fennec Pharmaceuticals Resubmits New Drug Application to U.S. Food And Drug Administration for Pedmark

March 28, 2022

• Cormedix Inc. Announces FDA Acceptance of Resubmission of New Drug Application for Defencath

March 29, 2022

• Santhera and ReveraGen Start Rolling NDA Submission to the FDA for Vamorolone for the Treatment of Duchenne Muscular Dystrophy

March 30, 2022

• Akebia Therapeutics Receives Complete Response Letter from the FDA for Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients
• U.S. Food and Drug Administration (FDA) Accepts for Priority Review Taiho Oncology’s New Drug Application for Futibatinib for Cholangiocarcinoma

March 31, 2022

• Outlook Therapeutics Submits Biologics License Application to the U.S. Food and Drug Administration for ONS-5010 as a Treatment for Wet AMD
• Reata Pharmaceuticals Completes Rolling Submission of New Drug Application for Omaveloxolone for the Treatment of Patients with Friedreich’s Ataxia

April 4, 2022

• Alnylam Announces 3-Month Extension of Review Period for New Drug Application for Vutrisiran

April 11, 2022

• scPharmaceuticals Inc. Announces Resubmission of Furoscix New Drug Application

April 12, 2022

• Aeglea BioTherapeutics Submits BLA to FDA for Pegzilarginase for the Treatment of Arginase 1 Deficiency

April 19, 2022

• US Food and Drug Administration Accepts New Drug Application for Daprodustat

April 21, 2022

• Revance Receives FDA Acceptance of BLA Resubmission for DaxibotulinumtoxinA for Injection for Glabellar Lines

April 27, 2022

• Fennec Pharmaceuticals Announces FDA Acceptance for Filing of New Drug Application Resubmission for Pedmark

May 2, 2022

• Axsome Therapeutics Receives FDA Complete Response Letter for New Drug Application for AXS-07 for the Acute Treatment of Migraine
• Coherus and Junshi Biosciences Receive Complete Response Letter from U.S. FDA for Toripalimab BLA
• Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)

May 4, 2022

• Hutchmed Receives Complete Response Letter from the U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors

May 9, 2022

• Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer’s Disease Under the Accelerated Approval Pathway

May 13, 2022

• Update on U.S. FDA Review of Biologics License Application (BLA) for Bimekizumab - Complete Response Letter

May 16, 2022

• scPharmaceuticals Inc. Announces FDA Acceptance of Furoscix New Drug Application
• Travere Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Sparsentan for the Treatment of IgA Nephropathy

May 17, 2022

• Cytokinetics Provides Regulatory Update Related to New Drug Application for Omecamtiv Mecarbil

May 20, 2022

• AbbVie Submits New Drug Application to U.S. FDA for Investigational ABBV-951 (Foscarbidopa/Foslevodopa) for the Treatment of Advanced Parkinson's Disease

May 23, 2022

• ImmunoGen Announces Acceptance of Biologics License Application for Mirvetuximab Soravtansine in Ovarian Cancer by US Food and Drug Administration with Priority Review
• US FDA Accepts for Review Biohaven's New Drug Application (NDA) Filing of Intranasal Zavegepant for the Treatment of Migraine
• ImmunityBio Submits Biologics License Application for N-803 Plus BCG for Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma in Situ

May 24, 2022

• Verrica Receives Complete Response Letter from the FDA for its NDA for VP-102
• FDA Accepts CSL Behring’s Biologics License Application for Etranacogene Dezaparvovec for Priority Review

May 25, 2022

• Phathom Pharmaceuticals Announces FDA Acceptance for Filing of Vonoprazan NDA for the Treatment of Erosive Esophagitis

May 26, 2022

• Reata Pharmaceuticals Announces FDA Filing Acceptance and Priority Review Designation for the NDA for Omaveloxolone for the Treatment of Patients with Friedreich’s Ataxia

May 31, 2022

• Lexicon Resubmits New Drug Application for Sotagliflozin for the Treatment of Heart Failure
• TG Therapeutics Announces FDA Extension of BLA PDUFA Date for Ublituximab to Treat Patients with RMS

June 1, 2022

• Eagle Pharmaceuticals Announces Submission of New Drug Application to U.S. Food and Drug Administration for Landiolol, a Beta-1 Adrenergic Blocker

June 2, 2022

• Gamida Cell Completes Rolling Biologics License Application Submission to the FDA for Omidubicel

June 3, 2022

• Amylyx Pharmaceuticals Receives Notification of PDUFA Date Extension for AMX0035 for the Treatment of ALS

June 13, 2022

• Mallinckrodt Announces Resubmission of Terlipressin to the FDA for the Treatment of Hepatorenal Syndrome

June 17, 2022

• Sierra Oncology Announces Submission of New Drug Application for Momelotinib to US Food & Drug Administration

June 22, 2022

• Menarini Group and Radius Health Submit New Drug Application to the U.S. FDA for Elacestrant

June 23, 2022

• Astellas Submits Fezolinetant New Drug Application to U.S. FDA

June 27, 2022

• Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitor
• Spero Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Tebipenem HBr New Drug Application

June 29, 2022

• Ipsen Announces U.S. FDA Priority Review for Palovarotene New Drug Application in Patients With Fibrodysplasia Ossificans Progressiva Following Resubmission

June 30, 2022

• Pfizer Announces Submission of New Drug Application to the U.S. FDA for Paxlovid
• Provention Bio Announces Extension of FDA User Fee Goal Date for Teplizumab to November 17, 2022

July 7, 2022

• Bausch + Lomb and Novaliq Announce Submission of New Drug Application for Investigational Treatment NOV03 (Perfluorohexyloctane)

July 12, 2022

• FDA Accepts Byondis’ Biologics License Application for [Vic-]Trastuzumab Duocarmazine (SYD985) in HER2-Positive Metastatic Breast Cancer

July 18, 2022

• Acadia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Trofinetide for the Treatment of Rett Syndrome
• Acer Therapeutics Announces Resubmission of New Drug Application for ACER-001 for Treatment of UCDs

July 19, 2022

• Avadel Pharmaceuticals Announces Tentative Approval of Lumryz (sodium oxybate) Extended-Release Oral Suspension

July 25, 2022

• Treosulfan NDA Resubmitted to FDA

July 26, 2022

• FDA Accepts Biogen’s New Drug Application and Grants Priority Review of Tofersen for a Rare, Genetic Form of ALS

July 27, 2022

• Lexicon Announces FDA Acceptance of New Drug Application for Sotagliflozin to Treat Heart Failure
• Cidara Therapeutics Submits NDA for Rezafungin

July 28, 2022

• ImmunityBio Announces FDA Acceptance of Biologics License Application for N-803 in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer Carcinoma In Situ

August 1, 2022

• Gamida Cell Announces FDA Acceptance of Biologics License Application for Omidubicel with Priority Review

August 9, 2022

• Reata Pharmaceuticals Announces Three Month Extension of the Review Period for New Drug Application for Omaveloxolone for the Treatment of Friedreich’s Ataxia

August 11, 2022

• Menarini Group’s Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer

August 17, 2022

• US FDA Accepts New Drug Application for GSK’s Momelotinib for the Treatment of Myelofibrosis

August 18, 2022

• U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant

August 22, 2022

• Minerva Neurosciences Submits New Drug Application to FDA for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia
• Notice on withdrawal of New Drug Application in the US of GnRH antagonist Linzagolix

August 25, 2022

• Iovance Biotherapeutics Initiates Biologics License Application (BLA) Submission for Lifileucel in Advanced Melanoma

August 31, 2022

• Amneal Announces Submission of New Drug Application to the U.S. FDA for IPX203 for the Treatment of Parkinson’s Disease
• Aquestive Therapeutics Receives FDA Tentative Approval for Libervant (diazepam) Buccal Film

September 6, 2022

• Bausch + Lomb and Novaliq Announce U.S. FDA Filing Acceptance for Investigational Treatment NOV03 (Perfluorohexyloctane)

September 7, 2022

• Tarsus Submits New Drug Application to the FDA for TP-03 for the Treatment of Demodex Blepharitis
• Amylyx Pharmaceuticals Announces FDA Advisory Committee Supports Approval of AMX0035 for the Treatment of ALS

September 9, 2022

• FDA and EMA Accept Regulatory Submission for Pfizer’s Ritlecitinib for Individuals 12 Years and Older with Alopecia Areata

September 12, 2022

• BioLineRx Announces Submission of New Drug Application (NDA) to FDA for Motixafortide in Stem Cell Mobilization
• Acadia Pharmaceuticals Announces Trofinetide New Drug Application for the Treatment of Rett Syndrome has been Accepted for Filing and Review by U.S. FDA

September 20, 2022

• Cidara Therapeutics Announces FDA Acceptance for Priority Review of New Drug Application for Rezafungin for the Treatment of Candidemia and Invasive Candidiasis

September 22, 2022

• Spectrum Pharmaceuticals Provides Update on Poziotinib Following FDA Oncologic Drugs Advisory Committee Meeting

September 28, 2022

• Citius Pharmaceuticals, Inc. Submits Biologics License Application To The U.S. Food And Drug Administration For Denileukin Diftitox For The Treatment Of Patients With Persistent Or Recurrent Cutaneous T-Cell Lymphoma

September 29, 2022

• BioMarin Resubmits Biologics License Application (BLA) for Valoctocogene Roxaparvovec AAV Gene Therapy for Severe Hemophilia A to the FDA

October 6, 2022

• Visiox Pharma Submits New Drug Application Seeking Approval for First Once-Daily Brimonidine for Glaucoma

October 13, 2022

• Travere Therapeutics Provides Regulatory Update on its Sparsentan Program for IgA Nephropathy

October 17, 2022

• Minerva Neurosciences Receives Refusal to File Letter from FDA for its New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
• Biogen Announces FDA’s 3-Month Extension of Review Period for the New Drug Application for Tofersen

October 24, 2022

• Novaliq Announces FDA Acceptance of the New Drug Application for CyclaSol for the Treatment of Dry Eye Disease

October 26, 2022

• Seres Therapeutics Announces FDA Acceptance of Biologics License Application for Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection for Priority Review

October 27, 2022

• Gilead Receives Complete Response Letter from U.S. FDA for Bulevirtide for the Treatment of Adults with Hepatitis Delta Virus
• Santhera and ReveraGen Complete NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy

October 28, 2022

• Genmab Announces Submissions of Regulatory Applications for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma (LBCL) and Diffuse Large B-Cell Lymphoma (DLBCL)

November 3, 2022

• Iveric Bio Announces Submission of First Part of NDA for Rolling Review of Avacincaptad Pegol for the Treatment of Geographic Atrophy

November 10, 2022

• BioLineRx Announces U.S. FDA Acceptance of New Drug Application for Aphexda (motixafortide) in Stem Cell Mobilization

November 11, 2022

• Amneal Announces U.S. FDA Filing Acceptance of New Drug Application for IPX203 for the Treatment of Parkinson’s Disease

November 14, 2022

• UCB Announces U.S. FDA Acceptance of New Drug Application and EMA MAA Validation for Zilucoplan for the Treatment of Generalized Myasthenia Gravis in Adult Patients

November 17, 2022

• Iveric Bio Announces FDA Has Granted Breakthrough Therapy Designation for Avacincaptad Pegol for Geographic Atrophy

November 18, 2022

• Iovance Biotherapeutics Provides Update on Biologics License Application Submission for Lifileucel in Advanced Melanoma

November 21, 2022

• U.S. FDA Accepts for Priority Review the Biologics License Application for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma

November 22, 2022

• Opiant Pharmaceuticals Announces Completion of Rolling NDA Submission for OPNT003, Nasal Nalmefene, for Opioid Overdose
• GSK Provides an Update on Blenrep (belantamab mafodotin-blmf) US Marketing Authorization

November 25, 2022

• Spectrum Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for Poziotinib

November 28, 2022

• Sarepta Therapeutics Announces That U.S. FDA has Accepted for Filing and Granted Priority Review for the Biologics License Application for SRP-9001, Sarepta’s Gene Therapy for the Treatment of Ambulant Individuals with Duchenne Muscular Dystrophy

November 29, 2022

• Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for Reproxalap for the Treatment of Signs and Symptoms of Dry Eye Disease

December 1, 2022

• Citius Pharmaceuticals, Inc. Announces U.S. Food And Drug Administration Acceptance Of Biologics License Application Of Denileukin Diftitox For The Treatment Of Patients With Persistent Or Recurrent Cutaneous T-Cell Lymphoma

December 6, 2022

• Ocuphire Pharma Announces Submission of New Drug Application to FDA for Nyxol Eye Drops for Reversal of Mydriasis
• Biogen and Sage Therapeutics Complete Rolling Submission of New Drug Application for Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression

December 8, 2022

• Visiox Pharma Announces FDA Acceptance of New Drug Application for Glaucoma
• FDA Accepts Braeburn's New Drug Application Resubmission for Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

December 9, 2022

• FDA Accepts Biogen Biologics License Application for BIIB800, A Biosimilar Candidate Referencing Actemra® (tocilizumab)
• Janssen Submits Biologics License Application to U.S. FDA for Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

December 12, 2022

• Galera Submits New Drug Application for Avasopasem for Severe Oral Mucositis

December 13, 2022

• Eyenovia Announces FDA Acceptance of New Drug Application for MydCombi™ for In-Office Pupil Dilation
• Cytokinetics Announces Outcome of FDA Advisory Committee Vote On Omecamtiv Mecarbil

December 19, 2022

• F2G Announces FDA Filing Acceptance Of New Drug Application For Olorofim For The Treatment Of Invasive Fungal Infections

December 20, 2022

• Idorsia Submits a New Drug Application to the US FDA for Aprocitentan for the Treatment of Patients with Difficult-to-Control Hypertension
• Iveric Bio Announces Completion of Rolling NDA Submission to FDA for Avacincaptad Pegol for the Treatment of Geographic Atrophy

December 21, 2022

• Pfizer Announces FDA and EMA Acceptance of Etrasimod Regulatory Submissions for Ulcerative Colitis
• Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for ADX‑2191 for the Treatment of Primary Vitreoretinal Lymphoma

December 23, 2022

• Valneva Completes BLA Submission to U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate
• Ipsen Receives Complete Response Letter for Palovarotene, an Investigational Treatment for Fibrodysplasia Ossificans Progressiva

December 26, 2022

• Harm Reduction Therapeutics' New Drug Application for RiVive™ Over-the-Counter Naloxone Nasal Spray Accepted and Granted Priority Review by FDA

December 27, 2022

• SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Nirogacestat for the Treatment of Adults with Desmoid Tumors

December 28, 2022

• Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia