Le Lézard

News by subject: FDA

2 february 2021

19:06
Galderma announces that the U.S. Food and Drug Administration (FDA) has approved Restylane® Defyne for the augmentation and correction of mild to moderate chin retrusion for adults over the age of 21.1 In 2020 alone, online searches for chin...

09:00
Inovytec, an innovator of multi-functional and user-friendly critical medical devices, announced today that it was granted FDA 510(k) clearance to market and sell its Ventway Sparrow ventilators in the United States. The ventilators are already...

08:01
DURECT Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved POSIMIR® (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under direct arthroscopic visualization to...

08:00
Johnson & Johnson Vision**, a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies***, today announced that the U.S. Food and Drug Administration (FDA) approved the TECNIS Eyhancetm and TECNIS Eyhancetm Toric II...


1 february 2021

08:01
Soliton, Inc., ("Soliton" or the "Company"), a medical device company with a novel and proprietary aesthetic platform technology, today announced that the U.S. Food and Drug Administration ("FDA") has cleared its Rapid Acoustic Pulse ("RAP")...

08:00
Galderma announces that the U.S. Food and Drug Administration (FDA) has approved Restylane® Defyne for the augmentation and correction of mild to moderate chin retrusion for adults over the age of 21.1 In 2020 alone, online searches for chin...


29 january 2021

09:00
Medtronic plc , the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of the DiamondTemptm Ablation (DTA) system which treats patients with recurrent, symptomatic paroxysmal atrial...


28 january 2021

19:26
Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the US Food and Drug Administration...

11:10
icotec ag, a leading medical device manufacture of BlackArmor® Carbon/PEEK implants, announces the United States market release of the world's first 100% nonmetallic (Plate and Screws) Anterior Cervical Plate System after recently receiving U.S....

09:30
Co-Diagnostics, Inc. (the "Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that it has completed its submission to the U.S. Food and Drug Administration...

09:00
Immunoforge, the company specializing in the development of new drugs for rare musculoskeletal diseases (Representatives: An Seong-Min and Jang Gi-Ho), announced that their new drug candidate PF1801 has been designated as the FDA orphan drug for...


27 january 2021

19:00
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology,...

07:30
Q BioMed Inc. , announced today that the U.S. Food and Drug Administration's Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B, a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma...


26 january 2021

19:26
Samsung Biologics (KRX: 207940.KS) announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company's track record as a premiere CDO service...

13:41
Inspired Spine has announced the Trident SI Joint Screw System, manufactured by Advanced Research Medical (ARM), has secured FDA 510(k) marketing clearance. "We continue to raise the standard of care for back pain treatment as this SI Joint fusion...

09:00
Recordati Rare Diseases Inc. today announced the U.S. Food and Drug Administration (FDA) has approved a new indication for CARBAGLU® (carglumic acid) tablets 200mg as adjunctive therapy to standard of care for the treatment of acute hyperammonemia...


25 january 2021

17:45
According to a survey of more than 200 US rheumatologists and nephrologists in mid-2020, the unmet need for new treatments for lupus nephritis (LN) is exceptionally high. At the time, unaided awareness for agents in development was primarily limited...

10:00
PEDRAtm Technology, a privately-held company, announced today that the U.S Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for the periprocedural use of its PEDRAtm Xaurontm Perfusion System in the...

08:30
Theranica, a prescribed digital therapeutics (PDT) company developing advanced electroceuticals for migraine and other pain conditions, today announced that its Nerivio® therapeutic device has received the Food and Drug Administration clearance to...

08:00
OrthoSpin Ltd. ("OrthoSpin"), announced today that it received regulatory clearance from the United States Food and Drug Administration (FDA) for its second generation, robotic, digitally enabled external fixation system for orthopedic treatments....


23 january 2021

09:00
Spartan Bioscience announced today it has received approval from Health Canada and is now authorized to sell the Spartan COVID-19 System, a rapid, on-site molecular diagnostic test for the qualitative detection of SARS-CoV-2, the virus causing...


22 january 2021

21:12
For the second time in less than two months, the U.S. Food and Drug Administration (FDA) has approved a new medication to treat adults with lupus nephritis (lupus-related kidney disease) in combination with a background immunosuppressive therapy...

07:00
Boston Scientific Corporation has received U.S. Food and Drug Administration (FDA) approval of its fourth-generation Vercise Genustm Deep Brain Stimulation (DBS) System. The portfolio, approved for conditional use in a magnetic resonance imaging...


21 january 2021

16:21
The U.S. Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current...

13:16
Anivive, a pharmaceutical startup using software to develop novel therapeutics for pets, is delighted to announce that its first commercial product, LAVERDIA-CA1 (verdinexor), has been conditionally approved by the Food and Drug Administration (FDA)....

08:30
Most of the news on advances for Covid-19 tend to focus on vaccines, however treatments are just as important. While vaccines can stop people from contracting Covid and becoming seriously ill, treatments will still be needed for those who already...

07:30
Crescita Therapeutics Inc. and ("Crescita" or the "Company"), a commercial dermatology, today announced that Laboratoires FILLMED ("FILLMED") has submitted a New Medical Device License ("MDL") application for the ART FILLER® range of products....

07:00
Berkshire Biomedical, LLC ("Berkshire" or "the Company"), a privately-held digital health company developing a revolutionary virtual care and Intended User prescription drug management system, today announced that the Company's 510(k) application to...


20 january 2021

08:00
Impel NeuroPharma, a late-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's 5O5(b)(2) New Drug Application (NDA) for INP104 for the acute treatment of migraine...

08:00
RenovoRx, an innovator in targeted cancer therapy, today announced two research studies were presented at the 2021 ASCO Gastrointestinal Cancers Symposium that further advance the science of pancreatic cancer treatment. In one presentation,...


19 january 2021

09:45
Eitan Medical, a global leader in advanced infusion therapy and drug delivery solutions across the care continuum, announced today that its upgraded Sapphiretm infusion pump system software Rev15, which includes the infusion pump, administration sets...

08:00
Today, The Johnson & Johnson Medical Devices Companies* announced that DePuy Synthes** has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VELYStm Robotic-Assisted Solution designed for use with the ATTUNE® Total...

05:44
Occlutech, a privately-held company, announced today that the U.S Food and Drug Administration (FDA) has granted the Company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF)...


17 january 2021

05:00
Steba biotech, pioneering developer of the IMmune Photo Activate Cancer Treatment (ImPACT), announced today...


15 january 2021

17:30
Halozyme Therapeutics, Inc. today announced that Janssen Biotech, Inc. (Janssen) has received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide...

17:21
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with...


14 january 2021

10:00
SML Genetree announced today that it has received Emergency Use Authorization (EUA) from the U.S. FDA for the use of its Ezplex SARS-CoV-2 G Kit, a molecular diagnostic test for the qualitative detection of RNA from SARS-CoV-2 from nasopharyngeal...


13 january 2021

11:00
Vestibular First, a Philadelphia-based health-tech startup, is hosting a Live Streaming Launch Event on January 21st, 2021 for its patented Insight Infrared Video Goggles. These new FDA cleared goggles help clinicians cost-effectively differentiate...

09:05
Nuvo Group?a private company commercializing INVU by Nuvotm, an FDA-cleared, prescription-initiated, remote pregnancy monitoring platform?today announced that it has filed a 510(k) notice with the U.S. Food and Drug Administration (FDA) to add a new...


12 january 2021

08:56
JUD care, a leading high-tech enterprise in the field of smart medical and healthcare solutions, has obtained approval from the US Food and Drug Administration (FDA) for the portable ward sRoom ("sRoom"), a revolutionary solution for patient...

08:15
Creative Medical Technology Holdings Inc.  announced today filing of an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) requesting clearance to initiate the first clinical trial using cellular immunotherapy for...

07:30
The U.S. Food and Drug Administration has granted Emergency Use Authorization (EUA) to one of the first U.S.-manufactured serology tests designed by ADVAITE Inc., an innovative biotech company developing novel point-of-care assays to help with...

07:00
MicroVention, Inc., a U.S.-based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of...


11 january 2021

14:47
Today, the U.S. Food and Drug Administration conditionally approved Laverdia-CA1 (verdinexor tablets) to treat dogs with lymphoma, a type of cancer of the lymph nodes and lymphatic system. Laverdia-CA1 works to prevent certain proteins from leaving...

09:00
Abbott  has received 510(k) clearance for the first rapid handheld traumatic brain injury (TBI) blood test, which will help clinicians assess individuals with suspected mild TBIs, including concussions. The test will run on Abbott's handheld i-STATtm...

09:00
Helix, the leading population genomics company, has received de novo authorization from the U.S. Food & Drug Administration (FDA) for the Helix® Laboratory Platform, a whole exome sequencing platform with coverage of approximately 20,000 genes. This...


7 january 2021

07:02
Respicardia, Inc., the manufacturer of the only FDA-approved active implantable system for the treatment of central sleep apnea (CSA), announced today that Highmark Blue Cross Blue Shield and its affiliates will provide coverage for the Company's...

02:20
UNION therapeutics A/S (UNION) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in...


6 january 2021

09:00
The 510(k) premarket notification letter indicates that the FDA has determined that SQuEEZ may be legally marketed in interstate commerce according to its indications for use. SQuEEZ is an image analysis software application for cardiac Computer...

06:00
A world-first, AI powered, outcomes-driven, decision support tool ? EchoGo Pro, has been cleared by the FDA and is now available to clinicians across the U.S. EchoGo Pro was trialed and validated in the UK and US, improving the diagnostic accuracy of...