Le Lézard

News by subject: FDA

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12 april 2019

13:29
The U.S. Food and Drug Administration today granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or...

11:55
Sprout Pharmaceuticals is pleased to announce that the FDA has decided that existing warnings and restrictions regarding alcohol use in women taking Addyi® (flibanserin) for the treatment of acquired, generalized hypoactive sexual desire disorder...

10:07
Novel physiologic results on world elite freedivers' using the non-invasive MediPines Gas Exchange Monitor (https://bit.ly/2YVAG1M) were presented at the Experimental Biology 2019 conference. Dr. Philip Ainslie, Co-Director of the Centre for Heart,...


11 april 2019

18:48
Omega Medical Imaging announces the launch of FluoroShieldtm in conjunction with technology partner IKOMED Technologies, Vancouver, BC Canada. FluoroShieldtm is an Artificial Intelligence powered Region of Interest (ROI) Radiation exposure reduction...

17:00
Omron Healthcare, Inc., the global leader in personal heart health and wellness technology, has secured FDA clearance on its new Completetm, the first blood pressure monitor with EKG capability in a single device, and will open pre-orders on April...

14:43
Sanofi Genzyme, the Specialty Care Business Unit of sanofi-aventis Canda Inc, announced today that Health Canada has issued a Notice of Compliance with conditions (NOC/c) for LibtayoTM (cemiplimab) for the treatment of adult patients with metastatic...


10 april 2019

07:46
Getinge is today announcing clearance from the US Food & Drug Administration (FDA) for a new software version for the Servo-u® and Servo-n® mechanical ventilator platform. This software release includes the addition of Servo Compass® and High Flow...

07:30
Qilu Puget Sound Biotherapeutic Corp. (Sound Biologics), an emerging biotechnology company dedicated to developing next generation antibody combination therapies, today announced that U.S. Food and Drug Administration (FDA) has accepted the Company's...


9 april 2019

15:57
Amgen and UCB (Euronext Brussels: UCB) today announced that the U.S. Food and Drug Administration (FDA) has approved EVENITYtm (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY is the...

15:06
The U.S. Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or multiple risk factors...

09:00
Innoblative Designs, Inc. (Innoblative), a private medical device company committed to developing next generation, advanced-energy surgical solutions, announced it received U.S. Food and Drug Administration (FDA) clearance for its SIRAtm RFA...

08:05
Ortho Clinical Diagnostics' VITROS® XT MicroSlides, featuring new, multi-test technology that allows labs to run two tests simultaneously on one MicroSlide, have been cleared for market by the U.S. Food and Drug Administration. The product pairs...

03:01
Epson today announced that ink used in its SurePress® digital inkjet label presses and ColorWorks® on-demand color label printers are compliant with EU Regulation framework (EC) No. 1935/2004, Good Manufacturing Practices Regulation (GMP) (EC) No....


8 april 2019

15:32
The U.S. Food and Drug Administration today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no...

09:15
Platelet testing and research company Aggredyne, Inc. has received U.S. Food and Drug Administration (FDA) clearance for its unique AggreGuide A?100® ADP Assay testing cartridge, a cost-effective in vitro diagnostic device used to measure the effect...

07:30
GT Biopharma, Inc. (GTBP.PA) an immuno-oncology biotechnology company focused on innovative treatments based on the Company's proprietary NK-engager (TriKE) platform and Multi-Target Bispecific Drug Conjugate (MTBDC) platform, announced today it has...


4 april 2019

14:38
The U.S. Food and Drug Administration today is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative...

09:53
Magstim has received FDA clearance to include intermittent Theta Burst Stimulation (iTBS) as a treatment for Major Depressive Disorder with its Horizon ® TMS Therapy systems. The Horizon ® system was designed to offer...


3 april 2019

11:00
Management Concepts, Inc. received approval on a $100 million, 5-year Blanket Purchase Agreement from the Food and Drug Administration for workforce development, training and consulting services. The BPA, awarded through the FDA University (FDAU),...

11:00
Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the musculoskeletal space, located in "The Orthopedic Capital of the World," Warsaw, Ind., today announced it has recently received 510(k) clearance by the Food &...

09:06
Scientific Analytics Inc. ("SAI") today announced it has received FDA 510K medical device designation issued for its groundbreaking computer-vision-powered motion analysis technology, DARI Health, and formed a strategic collaboration with Hospital...

06:55
ACell, Inc. today announced that it has received a new 510(k) clearance from the US Food and Drug Administration (FDA) covering several devices in its Gentrix® Surgical Matrix suite of products. The clearance updates the...


2 april 2019

10:15
The ENvue Electromagnetic Feeding Tube Placement (EFTP) system is designed to enable accurate positioning of feeding tubes at the patient's bedside Proven safe and effective in ENvue clinical trials, with no tube insertions into the pulmonary airways...

09:17
Channel Medsystems®, a company dedicated to bringing innovation to the delivery of women's healthcare, today announced that the U.S. Food and Drug Administration (FDA) has approved the Cerene® Cryotherapy Device as a new approach to treating heavy...

09:14
CoaguSense, Inc., a subsidiary of i-SENS (KOSDAQ:099190), announced today that the U.S. Food and Drug Administration (FDA) has cleared its second-generation prothrombin time/international normalized ratio (PT/INR) monitoring system. The Coag-Sense®...

08:30
Emmes today announced that it provided the data management support for a study, funded by the National Institutes of Health (NIH) and approved by the Food and Drug Administration (FDA), to safely use Acyclovir to treat infants infected with the...

05:45
ChoiceSpine LLC, a privately-held spinal device manufacturer based in Knoxville, TN, was granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market HAWKEYE Ti, a 3D Printed Titanium Vertebral Body Replacement (VBR) device,...


1 april 2019

08:17
US WorldMeds has announced that Sloan Pharma, S.a.r.l., a subsidiary of US WorldMeds Holdings, LLC, has received approval from the U.S. Food and Drug Administration (FDA) for the reintroduction of Zelnormtm (tegaserod), a twice-daily oral treatment...

07:00
TCR2 Therapeutics Inc. , a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer, today reported financial results for the fourth quarter and full year ended December 31, 2018...


29 march 2019

19:55
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved MAVENCLAD® (cladribine) tablets for the treatment of adults with...

17:30
The U.S. Food and Drug Administration today approved Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease. Mavenclad is not...


28 march 2019

14:33
The U.S. Food and Drug Administration today approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of...

09:30
Mundipharma EDO GmbH, and Imbrium Therapeutics L.P., an operating subsidiary of Purdue Pharma L.P., today...


27 march 2019

15:05
The U.S. Food and Drug Administration today approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical conditions, such as...

10:16
MiRus has received FDA 510(k) approval for the MoRe® based Europatm Pedicle Screw System making it the first FDA approved medical device with this new class of implant material.  The Europatm System received the 2018 Spine Technology Award at the...

08:30
Innovative Neurological Devices is pleased to announce receiving the FDA market clearance for the Cervellatm Cranial Electrotherapy Stimulator. The FDA cleared the Cervella medical device for treatment of anxiety, depression, and insomnia. Cervella...

06:52
Lannett Company, Inc. today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Aspirin and Extended-Release Dipyridamole Capsules, 25 mg/200 mg, the therapeutic...

00:40
Novartis today announced that the US Food and Drug Administration (FDA) has approved Mayzent® (siponimod) for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome (CIS, is defined as a first episode of...


26 march 2019

19:16
The U.S. Food and Drug Administration today approved Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive...

07:00
Selvita (WSE: SLV), a clinical stage company engaged in the research and development of novel cancer therapies as well as provision of drug discovery and development services, today announced that the U.S. Food and Drug Administration (FDA) has...


25 march 2019

09:33
Slayback Pharma LLC announced today that it has received final approval for Hydroxyprogesterone Caproate Injection, USP 250 mg/ 1 ml.  This is the second ANDA approved by the FDA for Hydroxyprogesterone Caproate Injection in a preservative-free...

07:00
Zimmer Biomet Holdings, Inc. , a global leader in musculoskeletal healthcare, today announced U.S. Food and Drug Administration 510(k) clearance of the ROSA® ONE Spine System for robotically assisted minimally invasive and complex spine surgeries,...


21 march 2019

14:50
Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCMtm therapy, announced today that it has received approval from the United States Food and Drug Administration for its first-in-class Optimizer Smart System (link...

13:18
The U.S. Food and Drug Administration today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization...

08:33
GenePOC Inc., member of the Debiopharm Group, announces its third test to be cleared by the FDA, the GenePOC Strep A assay, to be used with the revogenetm device. About Group A Streptococcus (GAS) infection GAS is the most common bacterial etiology...

08:00
Beckman Coulter, a global leader in clinical diagnostics, announced today that its DxH 520 hematology analyzer has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), and is now available for sale in the United States....

07:00
Enzyvant, a biopharmaceutical company focused on developing and commercializing transformative therapies for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease and Fast...


20 march 2019

18:53
Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) approved Sunositm (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep...


19 march 2019

09:30
We all know the FDA is the arm of the U.S. government that, among other things, controls and oversees the approval process for medical device products and technologies are used in the diagnosis, prevention and treatment of diseases. It is estimated...

08:00
Soliton, Inc., ("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"), completed the human trials of...

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