Le Lézard

News by subject: FDA

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25 april 2019

13:17
Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug...

08:37
Global biotherapeutics leader CSL Behring today announced that the US Food and Drug Administration (FDA) has approved 4- and 5-gram vial sizes for ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)], its therapy for treating Alpha 1 Antitrypsin Deficiency...


24 april 2019

10:15
Belite Bio, a drug development company targeting currently untreatable conditions in ophthalmology and metabolic diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND)...


23 april 2019

23:02
NeuroSigma, Inc., a Los Angeles-based bioelectronics company focused on commercializing Trigeminal Nerve Stimulation (TNS) technology for treating neurological and neuropsychiatric disorders today announced that its Monarch® eTNS® System (Monarch)...

18:19
AbbVie , a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved SKYRIZItm (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque...

17:17
Boston Scientific Corporation today announced it has received U.S. Food and Drug Administration (FDA) approval for the LOTUS Edgetm Aortic Valve System. Delivered via a minimally-invasive procedure, this transcatheter aortic valve replacement (TAVR)...

09:00
Rapid Medical, a company focused on the development of interventional neurovascular devices, announced today that it has completed an oversubscribed Series C financing of $20 million. The proceeds will be used for the completion of the TIGER U.S. IDE...

09:00
AliveCor, the leader in FDA-cleared consumer electrocardiogram technology (ECG), today announced two additional FDA 510(k)-cleared indications, making KardiaMobile the only consumer ECG device in the world with FDA-clearance to detect the three most...

07:00
BAROnova, Inc., a medical device company focused on the development of first-in-class non-surgical solutions for the treatment of obesity, announced today that the U.S. Food and Drug Administration (FDA) has approved the TransPyloric Shuttle® (TPS®)...

04:00
Rapid Medical, a company focused on the development of interventional neurovascular devices, announced today that it has completed an oversubscribed Series C financing of $20 million. The proceeds will be used for the completion of the TIGER U.S. IDE...


19 april 2019

11:15
The U.S. Food and Drug Administration today granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose. The agency is...


18 april 2019

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, today announced that the U.S. Food and Drug Administration ("FDA") has...

07:00
A major milestone on its strategic mission to lead in sepsis diagnostics, Beckman Coulter today announced that its Early Sepsis Indicator has received 510(k) clearance from the U.S. Food and Drug Administration. Sepsis is a global healthcare crisis...


16 april 2019

08:00
Aquestive Therapeutics, Inc. , a specialty pharmaceutical company focused on developing and commercializing differentiated products to solve therapeutic problems, today announced that the U.S. Food and Drug Administration (FDA) has accepted the...

06:00
Aprea Therapeutics, a privately held, clinical stage biopharmaceutical company developing novel anticancer therapies targeting the tumor suppressor protein p53, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track...


15 april 2019

16:05
Novartis announced that the U.S. Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD), also known as neovascular AMD,...

16:00
Amgen today announced that EVENITYtm (romosozumab-aqqg) is now available for shipment to wholesalers in the U.S. EVENITY was approved by the U.S. Food and Drug Administration (FDA) on April 9, 2019, for the treatment of osteoporosis in...


12 april 2019

14:08
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that BALVERSAtm (erdafitinib) received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adults with locally advanced or metastatic...

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...

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