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
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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
DAIICHI-SANKYO: ENHERTU® Approved in the U.S. for HER2 Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2-Based Regimens
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate (ADC), for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
ASTELLAS: FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV™ (enfortumab vedotin-ejfv) for People with Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer
First-in-Class Antibody-Drug Conjugate Directed Against Nectin-4, a Protein Highly Expressed in Urothelial Tumors
FORWARD SCIENCE: Receives FDA Clearance for Orapeutic for Opioid Free Oral Pain Management
Forward Science received FDA Clearance for OrapeuticTM, a non-opioid oral pain relief gel. Forward Science is a MedTech company that operates R&D, its quality system, manufacturing, sales and support all from its Worldwide headquarters in Houston, TX.
GILEAD: Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults who are living with moderate-to-severe rheumatoid arthritis (RA). A priority review voucher was submitted with the NDA, shortening the anticipated time for review.
UROGEN PHARMA: Announces FDA Filing Acceptance and Priority Review of U.S. New Drug Application (NDA) for UGN-101
Potential for UGN 101 to be First Non-Surgical Therapy for the Treatment of Low-Grade Upper Tract Urothelial Cancer (LG UTUC)
EPIZYME: Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Follicular Lymphoma
Submission Marks On-time Execution of Second NDA Submission for Tazemetostat in 2019