Le Lézard

News by subject: FDA

24 may 2019

12:34
The U.S. Food and Drug Administration today approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe form of SMA and a leading...

08:00
Kelyniam Global (KLYG), a maker of custom cranial and craniofacial implants, announced today that it has received premarket approval from the Food and Drug Administration (FDA) for a new 510(k) application that allows for unique modifications to...


23 may 2019

21:33
THINK Surgical, Inc. ("THINK") announces completion of enrollment for the U.S. investigational clinical study and submission of the 510(k) to obtain clearance from FDA to market its active robot, TSolution One®, for use in total knee replacement...

14:50
Today, the U.S. Food and Drug Administration permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of...

10:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) 510(k) clearance for the cobas® TV/MG test for use on the cobas® 6800/8800 Systems for the detection of Trichomonas vaginalis (TV) and/or Mycoplasma genitalium...


22 may 2019

08:00
EpiBone, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted its Investigational New Drug (IND) clearance to proceed with a Phase 1/2 clinical trial of its lead bone product EpiBone-Craniomaxillofacial (EB-CMF), as a...

06:00
Mayne Pharma Group Limited is pleased to announce that the US Food and Drug Administration (FDA) has approved SORILUX® (calcipotriene) Foam, 0.005% in adolescents. SORILUX is now approved for treating plaque psoriasis of the scalp and body in...


21 may 2019

12:32
Today, healthcare innovation startup, NightWare, Inc., a privately-held digital therapeutics for mental health company, has received Breakthrough Status designation from the U.S. Food and Drug Administration (FDA). Nightware's lead product,...

09:12
Perrigo Company plc  today announced its partner received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application (ANDA) referencing Voltaren® Gel, 1% (diclofenac sodium topical gel, 1%). Perrigo...

06:21
PETAH TIKVA, Israel, May 21, 2019 PolyPid Ltd., a clinical-stage biopharmaceutical company focused on developing and commercializing novel, locally administered therapies, announced today that the United States Food and Drug Administration (FDA) has...


20 may 2019

08:00
Stryker announced today the Premarket Approval (PMA) of the Neuroform Atlas Stent System by the U.S. Food and Drug Administration (FDA).  Neuroform Atlas is only the second aneurysm adjunctive stent to be granted PMA approval for the treatment of...

07:00
UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application for the company's newest anti-epileptic drug (AED) NAYZILAM® (midazolam) nasal spray CIV, a benzodiazepine indicated for the acute treatment of...


17 may 2019

14:32
Body Vision Medical, a medical device company specializing in augmented real-time imaging, artificial intelligence and intra-body navigation, announced today that it has received clearance from the U.S. Food and Drug Administration to market their...

08:04
Takeda Pharmaceuticals, U.S.A., Inc. ("Takeda"), announced today that the U.S. Food and Drug Administration (FDA) approved extending the indication of GATTEX® (teduglutide) for injection to pediatric patients 1 year of age and older with Short Bowel...


16 may 2019

12:31
The U.S. Food and Drug Administration today approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older. VTE can include...

11:43
Magstim®TMS has launched the very first Transcranial Magnetic Stimulation navigation system specifically developed for the clinical market. StimGuide®, which has received FDA 510K clearance, is a unique navigation system...

08:00
GenePOC announces FDA clearance of its molecular diagnostic test for the detection and differentiation of the five most frequent gene sequences associated with carbapenem-non-susceptibility. QUÉBEC CITY, May 16, 2019 /PRNewswire/ ? GenePOC Inc.,...


15 may 2019

14:19
AbbVie , a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved VENCLEXTA® (venetoclax) in combination with obinutuzumab (GAZYVA®) for previously untreated patients with...

09:00
Aidoc, the leading provider of AI solutions for radiologists, announced today that it was granted Food and Drug Administration (FDA) clearance for an additional product in its expanding suite of AI-based workflow orchestration solutions. The...

06:00
AMDT Holdings, Inc. ? which develops new products to address existing and emerging needs in the extremity market ? has gained FDA clearance for its SixFixtm hexapod fixator device and an associated version of its SixFix deformity analysis and...


14 may 2019

19:44
BAVENCIO is the first anti-PD-L1 in combination with INLYTA approved by FDA for first-line treatment of patients with advanced renal cell carcinoma (RCC) Phase III study showed combination significantly lowered risk of disease progression or death by...

10:53
eMurmur® today announced that its flagship "eMurmur ID" solution has received FDA clearance, enabling a new era in heart murmur detection. eMurmur ID is a mobile and cloud solution which operates in conjunction with a 3rd party electronic...

08:07
TraceLink Inc., the world's largest integrated digital supply network providing real-time information sharing for better patient outcomes, today announced the acceptance of its participation in the Food and Drug Administration (FDA) Pilot Project...


13 may 2019

21:30
Haemonetics Corporation , a global medical technology company focused on delivering innovative hematology solutions to drive better patient outcomes, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA)...

16:19
Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection to treat all stages of diabetic retinopathy (DR), and thereby reduce the risk of blindness. Experience the...

14:45
EYLEA improves diabetic retinopathy and prevents worsening disease that can lead to blindness Diabetic retinopathy is the leading cause of blindness among working-aged American adultsRegeneron Pharmaceuticals, Inc. today announced that the U.S. Food...

10:52
Zebra Medical Vision (https://www.zebra-med.com/), the deep learning imaging analytics company, today announces that it has received FDA 510(k) clearance for HealthPNX - an AI alert for pneumothorax (PNX), based on chest X-rays....

08:27
Manufacturer Rehrig Pacific has announced that their FM Approved Non-Halogenated Flame Retardant pallet has been officially tested and certified to pass all requirements for FDA-regulated materials. This means that Rehrig's GMA NHFR pallets are both...

06:45
Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA® (ramucirumab injection, 10 mg/mL solution), as a single agent, for the treatment of patients with hepatocellular carcinoma (HCC) who have an...

06:00
Tenex Health, Inc., a privately held U.S.-based medical technology company providing healthcare professionals with minimally invasive technologies to treat chronic pain in soft and hard tissue, received 510(k) clearance from the United States Food...

06:00
BGN Technologies, the technology transfer company of Ben-Gurion University (BGU), introduces a novel drug combination therapy, based on two FDA approved drugs, for protecting the blood-brain-barrier, and therefore preventing the development of...

03:01
AliveCor, the leader in FDA-cleared consumer electrocardiogram technology (ECG), today announced its third FDA clearance in three months, making KardiaMobile 6L the world's first available six-lead personal ECG device. This highly anticipated...


10 may 2019

15:50
The American National Standards Institute (ANSI), coordinator of the U.S. voluntary standardization system, has accredited Florida Certified Organic Growers, Inc. DBA Quality Certification Services in accordance with the international standard...

02:48
NeuroVive Pharmaceutical AB   today announced that the US Food and Drug Administration, FDA, has approved NeuroVive's IND (Investigational New Drug) application, enabling clinical studies in the US with the company's drug candidate NeuroSTAT in...


9 may 2019

22:05
HONG KONG, May 10, 2019 /PRNewswire/ -- Ally Bridge Group ("ABG"), a leading global life science investment group, announced today that it led an over-subscribed $65 million financing of Pulmonx Corporation, a global leader in diagnostic and...


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...