| FDA Reporter

POLARYX THERAPEUTICS: Submits Investigational New Drug Application to the U.S. FDA for the Treatment of Late Infantile Neuronal Ceroid Lipofuscinosis With PLX-200

By Press release submission | Jan 1, 2020

Polaryx Therapeutics Inc, a biotech company developing patient-friendly small molecule therapeutics for lysosomal storage disorders, such as Late Infantile Neuronal Ceroid Lipofuscinosis (LINCL) and other forms of NCL, announced that the Company has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for the treatment of patients with LINCL.

LANNETT: Receives FDA Approvals For Two Dosage Strengths Of Butalbital, Acetaminophen And Caffeine Capsules

FDA Approval

By Press release submission | Jan 1, 2020

Lannett Company, Inc. (NYSE: LCI) today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Butalbital, Acetaminophen and Caffeine (BAC) Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg. The two dosage strengths of BAC Capsules, have a combined estimated IQVIA market value of approximately $68.6 million for the 12 months ending October 2019, although actual generic market values are expected to be lower.

CRYOLIFE: Receives FDA Authorization to Commence PROACT Xa Clinical Trial

Reform

By Press release submission | Jan 2, 2020

Study Designed to Evaluate the Use of Apixaban in On-X Aortic Valve Patients

SCITECH DEVELOPMENT, LLC: Announces FDA Acceptance of Investigational New Drug (IND) Application for ST-001 nanoFenretinide in Patients with T-Cell Lymphoma

FDA Approval

By Press release submission | Jan 2, 2020

Company will present at Biotech Showcase™ 2020 on Monday, 01/13/20 at 11:15am PST in San Francisco, CA

CORREVIO: Receives Complete Response Letter From U.S. FDA for Brinavess and Provides Update on Recent Events

Regulation

By Press release submission | Jan 3, 2020

Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Brinavess™ (vernakalant IV), an anti-arrhythmic drug for the conversion of atrial fibrillation (AF).

IOTAMOTION: Submits De Novo Application To FDA For iotaSOFT™ Cochlear Implant Insertion System

Reform

By Press release submission | Jan 3, 2020

iotaMotion has filed a De Novo application with the FDA for authorization to market its iotaSOFT™ cochlear implant insertion system in the US.

SURGLASSES: Foresee-X Augment Reality Solution from SURGLASSES Is Registered with the FDA and Ready for Trauma Treatment

Regulation

By Press release submission | Jan 6, 2020

Foresee-X is a set of smart surgical glasses with functionality based on augmented and mixed reality technologies.

AVITA MEDICAL: Receives U.S. FDA Investigational Device Exemption Approval of Clinical Feasibility Study to Evaluate RECELL System for Vitiligo

Reform

By Press release submission | Jan 6, 2020

Study expected to commence in first half of 2020

MASIMO: Announces FDA Clearance for Neonatal RD SET® Pulse Oximetry Sensors with Improved Accuracy Specifications

FDA Approval

By Press release submission | Jan 6, 2020

Improved SpO2 Accuracy Now Available for All Patient Populations

U.S. FDA: Michigan-based food manufacturer agrees to stop production after repeated food safety violations

Regulation

By Press release submission | Jan 13, 2020

U.S. District Judge Sean F. Cox entered a consent decree of permanent injunction between the U.S. and Home Style Foods, Inc., and the company’s owner, Michael J. Kowalski, and quality manager, Juan Valesquez. Home Style Foods, Inc., a Michigan-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements.

BRIDGE BIOTHERAPEUTICS: Announces FDA IND Clearance for BBT-176, an EGFR TKI for NSCLC

FDA Approval

By Press release submission | Jan 20, 2020

US FDA cleared the IND application submitted in December 2019

POLARYX THERAPEUTICS: Receives IND Approval for PLX-200 From the FDA for the Treatment of Late Infantile Neuronal Ceroid Lipofuscinosis

Drug Shortages

By Press release submission | Jan 20, 2020

Polaryx Therapeutics, a biotech company developing patient-friendly small molecule therapeutics for lysosomal storage disorders announced today that the Company has received an Investigational New Drug Application (IND) approval from the U.S. Food and Drug Administration (FDA) for the treatment of LINCL patients with PLX-200.

GLAXOSMITHKLINE: US Food and Drug Administration (FDA) grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma

Patients

By Press release submission | Jan 21, 2020

Biologics License Application based on results from the pivotal DREAMM-2 study of immunoconjugate targeting B-cell maturation antigen (BCMA) in heavily pre-treated patient population who was refractory to an immunomodulatory drug and a proteasome inhibitor, and refractory or intolerant to an anti-CD38 antibody

VIVALNK: Announces World's First FDA Cleared Wearable ECG Sensor Platform

FDA Approval

By Press release submission | Jan 21, 2020

Reusable patch and software development kit gives solution providers direct control over data

THE FCS FOUNDATION: Familial Chylomicronemia Syndrome Foundation Commends FDA Decision to Create New Advisory Group to Support Rare Disease Drug Review Processes

Reform

By Press release submission | Jan 21, 2020

Action aligns with requests from FCS Foundation for FDA to be more flexible and hear the patient voice when considering review of drugs to treat FCS

CELULARITY: Announces FDA Clearance of Landmark IND for CYNK-001, an Allogeneic, Off-the-Shelf Cryopreserved NK Cell Therapy

FDA Approval

By Press release submission | Jan 22, 2020

Company to Initiate First U.S. Clinical Investigation of Allogeneic NK Cell Therapy administered Intravenously or Intratumorally in Patients with Glioblastoma Multiforme (GBM)

MOST SACRED HEART OF JESUS CARDIOLOGY: Newly Minted FDA Commissioner Dr. Stephen Hahn Receives Minneapolis FDA Affidavit From Dr. Nalini Rajamannan Regarding FDA Design Control Study Using a Non-Exempt Medical Device

By Press release submission | Jan 22, 2020

Minneapolis FDA confirms no plan to inform patients of non-exempt medical devices placed in 667 citizens

BIOHAVEN PHARMACEUTICALS: Biohaven's Verdiperstat Receives FDA May Proceed Letter To Initiate Trial In Amyotrophic Lateral Sclerosis Conducted By The Healey Center For ALS At Mass General

Reform

By Press release submission | Jan 22, 2020

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven" or the "Company"), a biopharmaceutical company with multiple late-stage neuroscience drug candidates in development, announced today that the U.S. Food and Drug Administration (FDA) has notified its collaborators at the Sean M. Healey & AMG Center for Amyotrophic Lateral Sclerosis (ALS) at Massachusetts General Hospital (MGH) that they may proceed with clinical investigation of verdiperstat, Biohaven's novel myeloperoxidase (MPO) inhibitor, in ALS.

BAZE: Boston-Based Personalized Nutrition Startup, Baze, Announces FDA Approval For Blood-Based Testing Kits

FDA Approval

By Press release submission | Jan 23, 2020

Regulatory approval enables company to expand reach of at-home kits, empowering consumers nationwide to take control of their health

CLENE NANOMEDICINE: Announces Formal Acceptance of CNM-Au8 for HEALEY ALS Platform Trial as Center Receives FDA Approval to Proceed

FDA Approval

By Press release submission | Jan 24, 2020

Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced the receipt of formal acceptance from the U.S. Food and Drug Administration (FDA) to proceed with its CNM-Au8 as one of the first three drug regimens in the HEALEY ALS Platform Trial being conducted by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital.

Latest News

Newsletter

FDA Reporter