Le Lézard

News by subject: FDA

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8 may 2019

15:34
Amerigen Pharmaceuticals Limited ("Amerigen") today announced that Amerigen's Abbreviated New Drug Application ("ANDA") for Penicillamine Capsules USP 250 mg has received final approval from the U.S. Food and Drug Administration. This is the first...

13:30
CryoConcepts, LP, a market leader in the development and manufacture of cryosurgical products, announced today they have received FDA clearance on two new, patent pending, cryosurgical devices for the physician's office market.   ...

12:26
SafeTraces, Inc. announced today that the U.S. Patent and Trademark Office granted the company a U.S. Patent titled DNA Based Bar Code for Improved Food Traceability. The patent discloses a novel method for encoding and decoding digital information...

12:14
Optina Diagnostics announces today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its retinal imaging platform (CAPRS1/MHRC2). Optina Diagnostics' platform uses Artificial Intelligence (AI) to analyze...

08:32
Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCMtm therapy, announced today that the first patient to receive the Optimizer Smart System since the device was approved by the U.S. Food and Drug Administration...

08:00
United Imaging Healthcare (UIH), an international leader in advanced medical imaging and radiotherapy equipment, announced the U.S. Food and Drug Administration (FDA) clearance of the uPMR 790 HD TOF PET/MR. uPMR 790 redefines clinical routine...


7 may 2019

14:32
Recros Medica, Inc. announced today that its de novo regulatory submission for the Nuvellustm Focal Contouring System has been accepted for review by the US Food and Drug Administration (FDA). Nuvellus utilizes the company's proprietary Rotational...

09:01
The Global Health Investment Fund (GHIF) and Medicines Development for Global Health (MDGH) today announced the sale of  MDGH's Priority Review Voucher (PRV). The PRV was awarded to MDGH in June 2018 by the U.S. Food & Drug Administration (FDA)...

09:00
Rapid Medical, a company focused on the development of next generation neurovascular devices, today announced that its Comaneci device received FDA clearance as a Temporary Coil Embolization Assist Device. The Comaneci is the first and only device in...

07:00
BioLineRx Ltd.  , a clinical-stage biopharmaceutical company focused on oncology, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AGI-134, a novel immunotherapy...

06:00
United Therapeutics Corporation and DEKA Research & Development Corp. today announced receipt of 510(k) clearance by the U.S. Food and Drug Administration (FDA) for the Unity Subcutaneous Delivery System for Remodulin (treprostinil) Injection, also...

04:00
Rapid Medical, a company focused on the development of next generation neurovascular devices, today announced that its Comaneci device received FDA clearance as a Temporary Coil Embolization Assist Device. The Comaneci is the first and only device in...


6 may 2019

17:36
The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. This is the first FDA approval of a treatment specifically...

08:48
On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin?mediated amyloidosis (ATTR-CM) in adults. These...


3 may 2019

13:19
The American Food and Drug Administration (FDA) issued a statement on Thursday in regards to the March 2019 public advisory hearing on breast implants and the related risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). They...

06:30
Caris Life Sciences®, a leading innovator in molecular science focused on precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the company's MI Transcriptometm companion...


2 may 2019

12:55
Glenmark Therapeutics Inc., USA, a wholly-owned subsidiary of Glenmark Holding SA., today announced a co-promotion agreement with Otonomy, Inc. , a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology....


1 may 2019

19:10
The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have...

18:35
The U.S. Food and Drug Administration (FDA) approved Dengvaxia® (Dengue Tetravalent Vaccine, Live) for the prevention of dengue disease caused by serotypes 1 ? 4 of the virus in individuals 9 through 16 years of age living in endemic areas of the...

08:00
Heron Therapeutics, Inc. , a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that it received a...

07:00
This May, for Vision Health Month, Bausch + Lomb Canada is launching the Why Eye Care campaign to encourage Canadians to join the vision health movement and to fund vital research. To inform and empower Canadians about vision health by raising...


30 april 2019

17:00
Biofourmis announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its RhythmAnalyticsTM platform, a cloud-based software for automated interpretation of cardiac arrhythmias. It uses an enhanced...

13:41
The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17. Mavyret was previously approved to treat HCV in adults in 2017....

11:00
InDevR Inc., a leader in progressive analytical technologies, announced today that they have received 510(k) market clearance for their FluChip-8G Influenza A+B Assay from the United States Food and Drug Administration (FDA). FluChip-8G is the first...

10:35
Mayne Pharma Group Limited is pleased to announce that the US Food and Drug Administration (FDA) has approved the trade name LEXETTEtm for the approved drug halobetasol propionate foam, 0.05%. LEXETTE is a new formulation of halobetasol, a potent...

08:00
Phoenix Tissue Repair, Inc., a biotechnology company focused on developing disease-modifying treatments, today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for PTR-01, an investigational protein...

06:59
BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) approval for BD ChloraPreptm skin preparation with sterile solution, the only fully sterile...


29 april 2019

09:00
CoapTech LLC, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today that the U.S. Food and Drug Administration (FDA) on April 10, 2019 granted the company 510(k) clearance for its...

08:00
Ampio Pharmaceuticals, Inc. today announced that it has received comments from the U.S. Food and Drug Administration (FDA) regarding their Special Protocol Assessment (SPA). The FDA recommended the Company not start their confirmatory trial without...

06:00
United Therapeutics Corporation today announced that its collaborator, XVIVO Perfusion, Inc., a subsidiary of XVIVO Perfusion AB (STO: XVIVO), has received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the products...


26 april 2019

19:19
Praluent is the first PCSK9 inhibitor that has shown a meaningful reduction in death from any cause Praluent treatment effect was observed in patients already receiving other lipid-lowering therapies, including maximally-tolerated statinsRegeneron...

16:25
The U.S. Food and Drug Administration today approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that were initially thought...

15:50
GSK today announced that the US Food and Drug Administration (FDA) has approved, under priority review, the use of the intravenous (IV) formulation of Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibitor, in children with lupus...

15:30
Eli Lilly and Company announced today that Taltz® (ixekizumab) met the primary and all major secondary endpoints in COAST-X, a Phase 3 study evaluating the safety and efficacy of Taltz for the treatment of non-radiographic axial spondyloarthritis...


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,...

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