Le Lézard

News by subject: FDA

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16 april 2021

11:54
Today, the U.S. Food and Drug Administration approved Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and...


15 april 2021

08:53
The US Food and Drug Administration (FDA) has approved Illuminare-1, a small molecule, myelin binding agent, for their Investigational New Drug Application (IND). Illuminare-1 is being developed as a surgical adjunct to improve the visualization and...


14 april 2021

16:01
BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Pristinetm Long-Term Hemodialysis Catheter, a new hemodialysis...

09:25
Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced...

07:10
Moleac, a biopharmaceutical company based in Singapore, announced the approval by the U.S. Food and Drug Administration (FDA) of an investigational new drug (IND) application for MLC1501 in traumatic brain injury (TBI). Moleac is dedicated in...


13 april 2021

09:30
Avitus Orthopaedics, a medical device company, today announced that it has received FDA clearance for the expanded indications for use of its Avitus® Bone Harvester technology. This FDA clearance allows for the use of the Avitus® Bone Harvester to...

09:16
Kibow Biotech, Inc., a clinical-stage biotechnology company pioneering the discovery and development of probiotics and prebiotics (synbiotics) for the treatment of kidney diseases beyond gut health, today announced that the U.S. Food and Drug...

08:00
UL, the global safety science leader, has received designation as an accredited  ISO/IEC 17025 laboratory under the U.S. Food and Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA), a voluntary pilot program for medical...

07:00
LumiraDx  announced today that it has received a reissued Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for LumiraDx SARS-CoV-2 RNA STAR Complete, a rapid, nucleic acid amplification method for high sensitivity,...

07:00
MEI Pharma, Inc. , a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, and Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), a global specialty pharmaceutical company that strives to create new value through the...


12 april 2021

13:20
Novartis today announced that the US Food and Drug Administration (FDA) approved the supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection in appropriate patients across all approved US indications.1...

09:00
MyHomeDoc today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the MyHomeDoc system, which uses a multi-sensor device to remotely examine the mouth, throat, lungs, ears, heart, skin, abdomen, body temperature, and oxygen...

07:45
Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation and confirmed the acceptance for substantive review of the supplemental New...

01:00
Cosmo Pharmaceuticals NV (SIX: COPN) today announced the FDA approval of GI Geniustm intelligent endoscopy system, its revolutionary device for lesion detection during colonoscopy....


9 april 2021

18:04
Today, the U.S. Food and Drug Administration authorized marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in...

09:00
Activ Surgicaltm, a digital surgery pioneer, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company's ActivSighttm Intraoperative Imaging Module for enhanced surgical visualization. The hardware agnostic imaging...

08:15
Regeneron Pharmaceuticals, Inc. announced today that newly updated National Institutes of Health (NIH) COVID-19 Treatment Guidelines strongly recommend that REGEN-COVtm (casirivimab with imdevimab) be used in non-hospitalized COVID-19 patients...


8 april 2021

20:10
Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced...

16:30
Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") , a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan...

08:06
Crown Aesthetics, a division of Crown Laboratories, Inc. and the US leader in Microneedling Technology, announced today that the U.S. Food and Drug Administration (FDA) has cleared SkinPen® Precision for the treatment of wrinkles on the neck....

08:00
GreenMarktm Biomedical Inc. announced that the company has secured regulatory clearance from the U.S. Food and Drug Administration ("FDA") to market its LumiCaretm Caries Detection Rinse as a 510(k) Class II Medical Device. "Gaining FDA clearance for...

07:00
The U.S. Food and Drug Administration (FDA) has granted Donisi's revolutionary contact-free multiparameter measurement system de novo clearance, making Donisi the first to bring this innovative technology to the medical market....


7 april 2021

10:00
Chemence Medical, a world leader in medical cyanoacrylate devices and products, announced the U.S. Federal Drug Administration's (FDA) 510(k) approval of the company's redesigned exofin fusion® skin closure system....

07:30
Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. ("Bausch Health"), today announced that the U.S. Food and Drug Administration (FDA) has approved ClearVisctm dispersive ophthalmic viscosurgical device (OVD) for use...

07:00
Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the U.S. Food and Drug...


6 april 2021

16:03
NuVasive, Inc. , the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the NuVasive Simplify® Cervical Artificial Disc (Simplify Disc) received...

13:26
nanoMeshtm LLC, a subsidiary of Exogenesis Corporation, announced today that it has successfully completed filing of a second Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its first proprietary...

08:54
Respinova Ltd. is pleased to announce it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Pulsehalertm. Pulsehalertm is an innovative device that facilitates the opening of airways and clearance of secretions...

07:15
Ortho Regenerative Technologies Inc. ("Ortho RTI" or the "Company"), a clinical stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, today announced that it has submitted an Investigational...


5 april 2021

13:30
Vysioneer, the leader in Artificial Intelligence (AI) for cancer care, announced today it received the U.S. Food and Drug Administration (FDA) clearance for VBrain, the first-ever AI-powered tumor auto-contouring solution....

09:20
Surgical Information Sciences (SIS), a medical device company focused on improved targeting for deep brain stimulation (DBS) surgery, announced it recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market an...

08:30
PlantX Life Inc. ("PlantX" or the "Company") is pleased to announce that the Canadian Food Inspection Agency ("CFIA") has granted PlantX with a license to import packaged plant-based products from the United States to Canada (the "Import...

08:00
IceCure Medical Ltd. ("IceCure" or the "Company"), developer of the next generation cryoablation technology that destroys tumors by freezing, announced today that it has been granted Designation as a Breakthrough Device from the U.S. Food and Drug...


1 april 2021

08:30
Lannett Company, Inc. today announced the submission of an Abbreviated New Drug Application (ANDA) for Fluticasone propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg) to the U.S. Food and Drug Administration (FDA), by...

08:00
SQI Diagnostics Inc. (the "Company" or "SQI") , a precision medicine company that discovers, develops and commercializes innovative rapid diagnostic testing for healthcare professionals, patients and consumers worldwide, announces that it has...

06:00
United Therapeutics Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved Tyvaso® (treprostinil) Inhalation Solution for the treatment of patients with pulmonary hypertension associated with interstitial lung...

00:07
BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its rapid antigen test to be used for SARS-CoV-2 screening...


31 march 2021

18:13
The U.S. Food and Drug Administration (FDA) has approved Sarclisa® (isatuximab-irfc) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one...

13:35
Althera Pharmaceuticals, a company focused on heart health, today announced the FDA approval of Roszet (rosuvastatin and ezetimibe) tablets, as an adjunct to diet, for treatment of elevated low-density lipoprotein cholesterol (LDL-C) in adult...

08:00
BioVaxys Technology Corp. (FRA:5LB)  ("BioVaxys"), the world leader in haptenized antigen vaccines for antiviral and cancer applications, announced today that it is has filed a pre-IND (Investigational New Drug) meeting request and submitted a...

08:00
Delfi Diagnostics, Inc., a pioneering developer of next generation high performance, affordable liquid biopsy tests for early cancer detection, announced the start of enrollment for a nationwide prospective study and plans to commercialize an initial...

07:39
Oxehealth has announced another world first after the US Food and Drug Administration granted a De Novo clearance for its Oxehealth Vital Signs product, which is incorporated into Oxevision, the vision-based patient monitoring and management platform...

07:00
CTI BioPharma Corp. today announced that it has completed a rolling New Drug Application ("NDA") submission to the U.S. Food and Drug Administration ("FDA") seeking approval of pacritinib as a treatment for myelofibrosis patients with severe...


30 march 2021

18:15
Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos® (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia...

14:01
NGMedical, a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application, announces FDA clearance for its anatomically shaped cervical interbody BEE® HA, made of the innovative PEEK-OPTIMAtm HA...

09:07
Biom Therapeutics, a clinical stage biotech company, announced today it has received orphan drug designation status for BIO017?which is designed to treat Angelman syndrome?from the U.S. FDA's Office of Orphan Product Development. Biom anticipates...

09:00
Nines announced the 510(k) FDA clearance for NinesMeasuretm, an innovative lung nodule measurement tool built with artificial intelligence (AI) that can accelerate diagnoses of certain respiratory diseases. "To our...

07:30
Moleculin Biotech, Inc., (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the U.S. Food and Drug Administration ("FDA")...

07:00
AI/ML Innovations Inc. , a company committed to acquiring and advancing Artificial Intelligence/Machine Learning technologies that address urgent societal needs, is pleased to announce that its subsidiary, Health Gauge, has secured key strategic...


29 march 2021

16:10
In the news release, International Myeloma Foundation Says FDA Approval of Bristol Myers Squibb's and bluebird bio's CAR T-Cell Immunotherapy Treatment for Multiple Myeloma Is Welcome News for Patients, issued 29-Mar-2021 by International Myeloma...

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