Le Lézard

News by subject: FDA

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6 may 2021

13:24
Medo, an artificial intelligence technology start-up company headquartered in Singapore and Canada, is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration for the world's first tool using Artificial...

09:00
Viome, a mission-driven bioscience company focused on helping individuals improve their health, today announced its proprietary mRNA analysis technology combined with its next-generation AI platform has been designated a Breakthrough Device by The...

08:00
MY01 Inc. is on a mission to empower healthcare professionals with the ability to pre-empt severe medical conditions, improving patient outcomes. MY01 inc. today announced U.S. Food and Drug Administration 510(k) clearance for the MY01 Continuous...

08:00
Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, today announced that the U.S. Food and Drug Administration (FDA) has approved a single 1000 mg dose option of Injectafer® (ferric carboxymaltose injection), an iron...


5 may 2021

09:00
Amgen today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Otezla® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are...

08:10
OncoRes Medical has received a Breakthrough Device designation from the U.S. Food and Drug Administration to expedite development of its Quantitative Micro-Elastography (QME) Imaging System. The company's technology is designed to provide real-time...

07:30
Servier Pharmaceuticals, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug...

06:57
Genesis Software Innovations "GSI," a company that has created an innovative foundational platform solution in the orthopedic space, announced today that they have received FDA clearance for their PreViewtm 3D Shoulder Arthroplasty Planning Software....


4 may 2021

21:00
The U.S. Food and Drug Administration (FDA) has granted Donisi's revolutionary contact-free multiparameter measurement system de novo clearance, making Donisi the first to bring this innovative technology to the medical market. In addition to the de...

09:08
Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, is pleased to announce that it has received a response from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug...

09:08
Quercis Pharma AG, a private, clinical stage biopharmaceutical company leveraging its novel antithrombotic platform, today announces that it has entered into a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration...

08:00
Micro Medical Solutions (MMS), an emerging leader in the treatment of CLTI, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its MicroStent vascular stent. This novel technology is...

03:00
Standard Bariatrics® announced today that its novel Titan SGStm stapling technology, designed specifically for bariatric sleeve surgery, has been cleared by the US Food and Drug Administration (FDA).1 The Titan SGStm first-of-its-kind design offers...


1 may 2021

12:28
Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today that the U.S. Food & Drug Administration (FDA) has approved FERRIPROX® (deferiprone) for...


30 april 2021

16:47
Today, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease...

09:25
The U.S. Food and Drug Administration announced today the approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose. The newly approved product delivers 8 milligrams (mg) of naloxone into the nasal cavity. The FDA...


29 april 2021

12:30
Lumenis Ltd., the world's largest energy-based medical device company for ophthalmic, aesthetic and surgical applications and the inventor of intense pulsed light (IPL) technology, today announced that the FDA has granted De Novo authorization for...

08:30
Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) for Chronic Inflammatory Demyelinating...

08:00
MOLLI Surgical Inc. today announces U.S. Food and Drug Administration clearance for MOLLItm, a new wire-free localization technology for breast cancer surgery. The new technology helps radiologists mark lesions quickly and accurately, and enables...

07:30
Tris Pharma, Inc. ("Tris"), a specialty pharmaceutical company with a robust portfolio of approved products and a late-stage pipeline of innovative product candidates for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and related...


28 april 2021

13:27
Protalix BioTherapeutics, Inc. , a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today...

09:28
International Medical Solutions ("IMS"), one of the first cloud-native technologies to enable the remote, seamless, and instant view of medical DICOM images in the cloud received FDA Class II Clearance for its mobile 3D cinematic solution. IMS is the...

09:25
Allegro MedSpa announced today that their facility has been selected as one of only a few practices in Northern California chosen to debut Qwotm, the first and only FDA-approved injectable for moderate to severe cellulite in the buttocks of adult...

08:00
Cosmo Pharmaceuticals N.V. (SIX: COPN) ( XETRA: C43) invites investors, financial analysts as well as business and trade media to a conference call Q&A session on the 4th of May 2021 to discuss GI Geniustm, the first device approved by the US Food...

06:21
Osteotec Limited have announced that they have obtained FDA registration for ChiroKlip, the powerful self-fixing disposable device that solves the problem of protecting the protruding ends of K-wires....

04:05
Calliditas Therapeutics AB ("Calliditas") today announced that the U.S. Food and Drug Administration (FDA) has accepted the submission and granted Priority Review for the New Drug Application (NDA) for Nefecon, a down regulator of IgA1 for the...

03:33
Amgen today announced that it agreed last night with the FDA's proposed post-marketing requirement to conduct, as part of the ongoing development program, a multi-center randomized clinical trial to compare the safety and efficacy of LUMAKRAStm at...


27 april 2021

09:00
Today, medical start-up MyHomeDoc announced that its brand name will from now on be known as NONAGON. The new branding will begin effective immediately on all products, digital assets, and communications worldwide. The NONAGON name refers to a...

08:00
Medtronic plc , the global leader in medical technology, today announced approval from the U.S. Food and Drug Administration (FDA) to proceed with an investigational device exemption (IDE) trial to evaluate its internally developed implantable tibial...


26 april 2021

09:25
Scopus BioPharma Inc. today announced the submission of an investigational new drug application ("IND") to the United States Food and Drug Administration ("FDA") for its immuno-oncology RNA therapy for the treatment of multiple cancers. The IND...

09:00
PathogenDx, Inc., an Arizona based biotechnology company, announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its patented COVID-19 multiplexed viral diagnostic assay, DetectX-Rv....

06:00
BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the BD Alaristm System, the most widely used...


23 april 2021

19:38
Johnson & Johnson (the Company) today announced that vaccinations with the Company's COVID-19 single-shot vaccine will resume for all adults aged 18 years and older in the U.S., under Emergency Use Authorization (EUA), following a decision from the...

10:28
MSN Labs, based in Hyderabad, India, received FDA approval to market their generic versions of Albendazole 200mg tablets (AB rated to Albenza©), Droxidopa 100mg, 200mg, 300mg capsules (AB rated to Northera ©), Deferasirox Granules 180mg, 360mg...


22 april 2021

16:33
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved JEMPERLI (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company's Biologics License Application....

13:15
Today, the U.S. Food and Drug Administration granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing...

08:21
Today, Getinge announces clearance from the US FDA of several new software options for the Servo-u and Servo-n ventilators. In addition to the latest software upgrades, Getinge also received clearance for the new Servo-u MR ventilator for the MRI...


21 april 2021

15:19
PBG BioPharma Inc., a life science company committed to becoming a world leader in the development and manufacturing of evidence-based natural health products and medicinal cannabis products using its proprietary GenBioChem® Triple Fingerprinting...

08:00
Medtronic plc , the global leader in medical technology, today announced it has received approval from the United States Food and Drug Administration (FDA) for Pipelinetm Flex Embolization Device with Shield Technologytm. Medtronic developed Shield...

08:00
ATCC, the world's premier biological materials management and standards organization, today announced that five high-quality, concentrated virus preparations that it produced and stored under contract from the U.S. Food and Drug Administration's...

06:03
Cerus Endovascular Ltd., a privately held, commercial-stage medical device company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to conduct a U.S. trial for the...

04:00
Johnson & Johnson Vision*, a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies**, today announced the FDA 510(k) clearance and CE mark of its next-generation phacoemulsification innovation, the VERITAStm Vision...


20 april 2021

16:30
EnsiteVascular announces today it received its second U.S. Food and Drug Administration (FDA) market clearance for the company's SiteSeal SV (small vessel) VCD to achieve hemostasis of the brachial artery after a transbrachial endovascular procedure....

16:00
Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces that it has resumed the launch of its generic version of GlaxoSmithKline's Advair Diskus®1 in the US following US FDA approval of an amendment Hikma submitted to...

09:00
Americans consider the CDC and FDA's decision to pause the Johnson & Johnson vaccine proof that rigorous safety monitoring is working, according to a national poll conducted April 15-16 by pollster Frank Luntz for the de Beaumont Foundation....


19 april 2021

08:00
Curis, Inc. , a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for CA-4948, a...

08:00
ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF), a global, research-driven pharmaceutical company that focuses on the diagnosis and treatment of allergies, announced that the U.S. Food and Drug Administration (FDA) approved RAGWITEK® (Short Ragweed...

07:08
CytoSorbents Corporation , a critical care leader whose flagship E.U. approved CytoSorb® blood purification technology is intended to treat deadly conditions in critically-ill and cardiac surgery patients, announces that the U.S. Food and Drug...


16 april 2021

15:52
Stuart Therapeutics (Stuart) announced today that the U.S. Food and Drug Administration (FDA) has completed its review of an Investigational New Drug (IND) application for Stuart's investigational product ST-100, a topical drop formulation designed...

13:00
Mayne Pharma announced today that the U.S. Food and Drug Administration (FDA) has approved NEXTSTELLIS (3 mg drospirenone [DRSP] and 14.2 mg estetrol [E4] tablets) for the prevention of pregnancy. NEXTSTELLIS is the first and only contraceptive pill...

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