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VIVALNK: Announces World's First FDA Cleared Wearable ECG Sensor Platform
Reusable patch and software development kit gives solution providers direct control over data
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GLAXOSMITHKLINE: US Food and Drug Administration (FDA) grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma
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
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POLARYX THERAPEUTICS: Receives IND Approval for PLX-200 From the FDA for the Treatment of Late Infantile Neuronal Ceroid Lipofuscinosis
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.
BRIDGE BIOTHERAPEUTICS: Announces FDA IND Clearance for BBT-176, an EGFR TKI for NSCLC
US FDA cleared the IND application submitted in December 2019
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U.S. FDA: Michigan-based food manufacturer agrees to stop production after repeated food safety violations
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.
MASIMO: Announces FDA Clearance for Neonatal RD SET® Pulse Oximetry Sensors with Improved Accuracy Specifications
Improved SpO2 Accuracy Now Available for All Patient Populations
AVITA MEDICAL: Receives U.S. FDA Investigational Device Exemption Approval of Clinical Feasibility Study to Evaluate RECELL System for Vitiligo
Study expected to commence in first half of 2020
SURGLASSES: Foresee-X Augment Reality Solution from SURGLASSES Is Registered with the FDA and Ready for Trauma Treatment
Foresee-X is a set of smart surgical glasses with functionality based on augmented and mixed reality technologies.
IOTAMOTION: Submits De Novo Application To FDA For iotaSOFT™ Cochlear Implant Insertion System
iotaMotion has filed a De Novo application with the FDA for authorization to market its iotaSOFT™ cochlear implant insertion system in the US.
CORREVIO: Receives Complete Response Letter From U.S. FDA for Brinavess and Provides Update on Recent Events
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).
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SCITECH DEVELOPMENT, LLC: Announces FDA Acceptance of Investigational New Drug (IND) Application for ST-001 nanoFenretinide in Patients with T-Cell Lymphoma
Company will present at Biotech Showcase™ 2020 on Monday, 01/13/20 at 11:15am PST in San Francisco, CA
CRYOLIFE: Receives FDA Authorization to Commence PROACT Xa Clinical Trial
Study Designed to Evaluate the Use of Apixaban in On-X Aortic Valve Patients
LANNETT: Receives FDA Approvals For Two Dosage Strengths Of Butalbital, Acetaminophen And Caffeine Capsules
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.
POLARYX THERAPEUTICS: Submits Investigational New Drug Application to the U.S. FDA for the Treatment of Late Infantile Neuronal Ceroid Lipofuscinosis With PLX-200
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.
JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON: Complete Response Letter Issued from U.S. FDA for Investigational Long-Acting HIV Regimen
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) in response to ViiV Healthcare's (ViiV) New Drug Application for the two-drug long-acting (LA) injectable regimen of ViiV's cabotegravir and Janssen's rilpivirine for the treatment of HIV-1 infection in adults. The regimen was co-developed as part of a collaboration between Janssen and ViiV.
VERO BIOTECH: Receives US FDA Approval of GENOSYL® for the Delivery of Inhaled Nitric Oxide
The GENOSYL® inhaled nitric oxide approval represents the first and only FDA-approved tankless delivery system and is an important new development in the clinical application of inhaled nitric oxide
SOLITON: Announces Successful Completion of Safety Testing at SGS to Support FDA Filing for Second Generation Device
Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), announced its Rapid Acoustic Pulse ("RAP") device successfully completed the IEC 60601 safety testing being conducted at SGS, the world's leading inspection, verification, testing and certification company. The testing was led by a team at Sanmina Corporation, a leading electronics manufacturing services provider.
INTERSCOPE: Announces new FDA Clearance of the EndoRotor®, for use in Airway procedures including in Interventional Pulmonology
Interscope, Inc. announced today the receipt of marketing clearance from the FDA for the EndoRotor® System to commercialize Pulmonary indications.
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VIIV HEALTHCARE: Receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.
MERCK: Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live)
Action Represents Another Milestone for the Global Partnership Against Ebola