Le Lézard

News by subject: FDA

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25 march 2021

10:00
SWABD aims to make wedding rescheduling and downsizing a thing of the past as they introduce "day-of" wedding COVID-19 tests to the US market. SWABD is a rapid COVID-19 Antigen test that allows for effective screening of the COVID-19 infection on a...

09:00
In a first of its kind approval, the FDA granted Emergency Use Authorization to Tiger Tech's COVID screening device. The timing couldn't be better with the new CDC guidelines which will help more schools re-open, more arenas open for sports, etc....

08:00
Thermo Fisher Scientific today announced the completion of the U.S. Food and Drug Administration (FDA) listing for the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System. The innovative product enables clinical laboratories and assay developers...


24 march 2021

11:00
People living with lupus will soon have access to a breakthrough treatment discovered by an Albertan life sciences entrepreneur, who is creating a more globally competitive drug commercialization industry in Canada. Dr. Robert Foster, an adjunct...

09:03
Natera, Inc. , a pioneer and global leader in cell-free DNA testing, today announced that the US Food and Drug Administration (FDA) has granted two Breakthrough Device Designations (BDDs) covering new intended uses of the Signatera molecular residual...

08:00
Tivic Health® Systems Inc., a first-in-class developer of bioelectronics health devices, today announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for use of ClearUP® Sinus Pain Relief to include congestion from...

07:00
ENTEROME SA, a clinical stage biopharmaceutical company developing novel drugs based on its unique ability to de-code molecular interactions in the gut microbiome impacting human health, today announces that it has received Investigational New Drug...


23 march 2021

10:00
MESI mTABLET ABI, device used for early detection of Peripheral Arterial Disease (PAD) by measuring Ankle-Brachial Index (ABI), was cleared for marketing and sales by the Food and Drug Administration in December 2020. MESI mTABLET ABI is a unique...

08:00
Ortho Clinical Diagnostics , one of the world's largest pure-play in vitro diagnostics companies, today announced it received authorization from the U.S. Food and Drug Administration to update key claims for the VITROS® SARS-CoV-2 Antigen Test, the...

07:05
The SERIES-5 MyoVision is an FDA-cleared, Class II medical device patented for diagnosing soft tissue injury. It effectively invalidates expert opinion by providing objective evidence of injury proving injury and exposing symptom magnifiers. The...


22 march 2021

13:02
Recovery Force, LLC is pleased to announce the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the use of the Movement and Compressions (MAC) System, a novel, data-driven, mobility measurement device designed for...

07:00
Oakrum Pharma, LLC ("Oakrum Pharma"), in collaboration with Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals"), announced today the U.S. approval of a generic version of JADENU®1 Sprinkle (Deferasirox Granules) in 90mg, 180mg, and 360mg strengths....


19 march 2021

08:09
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) approved PONVORYtm (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat...

07:00
Check-Cap Ltd. (the "Company" or "Check-Cap") , , a clinical stage medical diagnostics company advancing the development of C-Scan®, the first and only patient-friendly, preparation-free, screening test to detect polyps before they may transform into...


18 march 2021

08:30
Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation...

07:00
Boston Scientific Corporation announced it has received U.S. Food and Drug Administration (FDA) approval of the TheraSpheretm Y-90 Glass Microspheres, developed for the treatment of patients with hepatocellular carcinoma (HCC). The approval expands...


17 march 2021

10:00
4WEB Medical, an orthopedic device company focused on developing innovative implants with an Advanced Structural Design utilizing its proprietary Truss Implant Technologytm, announced today that the company has received 510(k) clearance from the U.S....

09:00
Medtronic plc , the global leader in medical technology, today announced the U.S. Food and Drug Administration (FDA) has approved revised commercial labeling for the Intellistm Platform with Differential Target Multiplexed (DTMtm) programming for the...


16 march 2021

08:45
Cytocom, Inc., a leading biopharmaceutical company creating next generation immune therapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 2 clinical trial to...

08:30
Sagimet Biosciences Inc., a clinical-stage biotechnology company focused on developing a portfolio of internally-discovered, selective fatty acid synthase (FASN) inhibitors, announced today that the U.S. Food and Drug Administration (FDA) has granted...

07:15
UVision360, Inc., an innovative FemTech company, announces today that the U.S. Food and Drug Administration (FDA) has accepted the Company's submission for expanded reprocessing procedures for use with the LUMINELLE DTx Hysteroscopy System. Supported...

07:00
CURCUGEN®, DolCas Biotech's bioavailability-enhanced, water-dispersible curcuminoid complex, has received Self-Affirmed Generally Recognized As Safe (GRAS) status. This designation was unanimously accorded by an independent panel of scientific...


15 march 2021

10:10
HomTex, an Alabama-based, minority-certified textile manufacturer announced today that it received FDA Emergency Use Authorization for its Level 1 Surgical masks, greenlighting their entry into the US government and medical Personal Protective...

07:00
Check-Cap Ltd. (the "Company" or "Check-Cap") , , a clinical stage medical diagnostics company advancing the development of C-Scan® , the first and only patient-friendly, preparation-free, screening test to detect polyps before they may transform...

02:58
Calliditas Therapeutics AB ("Calliditas") today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of...


11 march 2021

14:41
Veterans with long careers in the military and/or law enforcement are no stranger to the physical rigors that come with the job. Unfortunately, too many complete their service with injuries and pain that endures long after their duty ends. Despite...

13:00
The United States Food and Drug Administration (FDA) newly approved chlorine dioxide gas for contract sterilization of medical devices.  This breakthrough advancement for the medical industry was awarded to ClorDiSys Solutions, Inc, headquartered in...

09:45
Qardio, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510k clearance for its QardioCore ambulatory ECG device.  QardioCore will initially be marketed for holter monitoring applications, for use with...

07:00
Alkermes plc  today announced that nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230), the company's investigational engineered interleukin-2 (IL-2) variant immunotherapy, has been granted orphan drug designation for the treatment of...

07:00
Nuvation Bio Inc. , a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan...

00:52
Zymo Research announced today the U.S. Food and Drug Administration (FDA) has cleared its DNA/RNA Shieldtm Collection Tube as a Class II medical device. The FDA's 510(k) clearance allows the product to be used as an In-vitro Diagnostic (IVD) device...


10 march 2021

13:16
Today, the U.S. Food and Drug Administration issued emergency use authorization (EUA) to launch the GetMyDNA COVID-19 Test Home Collection Kit DTC, which is now available for broad use for both symptomatic and asymptomatic individuals with no...

09:00
Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small-molecule oncology therapeutics, today announced that the U.S. Food and Drug...

09:00
Leading medical design firm, Nectar Product Development, and its affiliated medical device company, BreathDirecttm, today announced that its BDR-19tm ventilator has received Emergency Use Authorization from the U.S. Food and Drug Administration...

06:52
Lannett Company, Inc. today announced that it recently received feedback from the U.S. Food and Drug Administration (FDA) regarding biosimilar insulin glargine, a product the company is co-developing with its strategic alliance partners within the...


9 march 2021

07:15
UVision360, Inc., an innovative FemTech company, announces today that the U.S. Food and Drug Administration (FDA) has accepted the Company's submission to expand the LUMINELLE® DTx System portfolio to now include the LUMINELLE 360° Bx (Biopsy)...

03:00
Molekule today announced that the U.S. Food and Drug Administration (FDA) cleared the 510(k) premarket notification for its existing air purifiers, Air Mini and Air Mini+, classifying them as Class II medical devices. Air Mini and Air Mini+ are now...

01:00
-- About 235,000 people in the US will be diagnosed with lung cancer in 2021, with non-small cell lung cancer (NSCLC) accounting for 84 percent of all lung cancers(1) -- ALK ? anaplastic lymphoma kinase ? is an important biomarker found in NSCLC, and...


8 march 2021

13:05
Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Asenapine Sublingual Tablets in 5mg strength (generic for Saphris®). Breckenridge...

13:04
Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Everolimus Tablets (generic for Afinitor®). This product was developed in...

11:41
Amniox Medical, Inc. (Amniox), a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, announced today that its parent company TissueTech had received clearance from the U.S. Food and Drug...

09:06
Cochlear Limited , the global leader in implantable hearing solutions, announces the U.S. Food and Drug Administration (FDA) clearance of the new Cochleartm Baha® 6 Max Sound Processor, designed to improve hearing outcomes for people with SSD...

08:31
BioMarin Pharmaceutical Inc. today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to valoctocogene roxaparvovec, an investigational gene therapy for the treatment of...

07:00
Mithra and Searchlight...

06:59
Viatris Inc.  and Kindeva Drug Delivery L.P. today announced that the U.S. Food and Drug Administration (FDA) granted tentative approval of budesonide/formoterol fumarate dihydrate products, the first generic version of Symbicort®  based on an...


5 march 2021

18:28
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next generation sequencing based (NGS) test to aid in identifying...

16:16
Cue Health Inc. (Cue) announced the healthcare technology company has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over the counter sale of its fast, accurate, COVID-19 test, making it the nation's...

15:13
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter  Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect...

09:00
Abbott today announced U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the company's Alinitytm m Resp-4-Plex molecular assay to detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial...

08:00
Kintor Pharmaceutical Limited (HKEX: 9939) is pleased to announce that the Investigational New Drug (IND) application of the phase III clinical trial of Proxalutamide's treatment of male COVID-19 outpatients has been approved by the United States...

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