Le Lézard

News by subject: FDA

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18 january 2024

08:20
Hoth Therapeutics, Inc. , a patient-focused biopharmaceutical company, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to implement a number of protocol amendments to its ongoing clinical trial for HT-001, which...

07:00
Nanoscope Therapeutics Inc., a late-stage clinical biotechnology company developing gene therapies for...

07:00
Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This multiplex vaginal panel can now be performed in near-patient settings, enabling results within 60...


17 january 2024

09:19
Immunity Pharma, a clinical-stage neurology-focused biopharmaceutical company, today announced positive...


16 january 2024

15:13
The first U.S. implantation of VasQtm since FDA De Novo was granted was successfully performed by Dr. Ari Kramer, Director and principal surgeon of Vascular Access Surgery at Spartanburg Regional Hospital in Spartanburg, SC. Developed by Laminate...

11:00
Bloomlife, the award winning maternal health company, has received clearance from the US Food and Drug Administration (FDA) for Bloomlife MFM-Pro, their first maternal and fetal monitoring device. This announcement comes on the heels of Bloomlife's...

10:00
Tarsier Pharma, Ltd., a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing first-in-class new therapies for the treatment of blinding ocular diseases, today announced it has received agreement from the U.S....

09:00
Presage Biosciences, a biotechnology company whose mission is to enable precision drug response evaluation in the human tumor microenvironment (TME), announced that the U.S. Food and Drug Administration (FDA) has issued a Study May Proceed...

08:30
Horizon Therapeutics plc, now part of Amgen, announced that on December 15, 2023, Health Canada approved UPLIZNA® (inebilizumab for injection)...

08:15
Halozyme Therapeutics, Inc. ("Halozyme") today announced that Takeda received U.S. Food and Drug Administration (FDA) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE® drug delivery technology for the...

08:00
PherDal Fertility Science, Inc., creators of the first and only sterile, at-home insemination kit, is now accepting pre-orders of its intravaginal insemination (IVI) device, following FDA class II clearance....

06:48
NRX-101 has demonstrated potent activity against resistant urinary pathogens upon FDA reviewQIDP designation grants Priority Review and an additional 5 years of additional product exclusivity 3 million Americans develop complicated Urinary Tract...


15 january 2024

00:15
AnX Robotica, the leader in advanced gastrointestinal visualization technologies, is thrilled to announce FDA clearance for expanded indications of its NaviCam Small Bowel Video Capsule Endoscopy (SB) in both adults and children aged 2 years and...


12 january 2024

08:08
FDA's De Novo approval of BrainSee represents a major advancement in Alzheimer's diagnostics. Utilizing cutting-edge image processing and medical AI, BrainSee establishes a new standard for predicting progression from amnestic mild cognitive...

05:13
RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, announced recently that its independently developed mesothelin (MSLN)-targeting antibody-drug conjugate (ADC), RC88, has been granted Fast...


11 january 2024

10:25
Endovascular Engineering ("E2"), a medical device company focused on the development and deployment of groundbreaking clot removal technologies that target venous thromboembolism (VTE), announced today FDA Investigational Device Exemption (IDE)...

07:00
Carl Zeiss Meditec AG -- ZEISS Medical Technology announced today that the U.S. Food and Drug Administration (FDA) has approved the VISUMAX® 800 with SMILE® pro software from ZEISS for surgically treating nearsightedness, with or without astigmatism....

06:00
Zeta Surgical, a surgical robotics and mixed reality company, announced today that its Zeta Cranial Navigation System has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded functionality through enhanced...

06:00
Neuralace Medical, Inc., an innovator in pain management technology, today proudly announces the FDA clearance of its groundbreaking product, Axon Therapy (mPNS), for the treatment of chronic Painful Diabetic Neuropathy (PDN). This landmark approval...

06:00
GenFleet Therapeutics, a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, announced that U.S. Food and Drug Administration (FDA) has recently granted another two designations for SLS009 (GFH009)....


10 january 2024

10:00
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09:37
PANTHERx® Rare, a leader in rare disease product patient access and support services in the United States, is pleased to announce that it was selected by UCB to dispense ZILBRYSQ®, a new FDA-approved therapy for the treatment of adults with gMG who...

09:00
Ultromics, a patient outcomes-focused AI-driven health technology company with roots at the University of Oxford, UK, has entered into an agreement with Pfizer to support the validation and FDA clearance of its AI-based technology for the detection...

06:00
Providence Medical Technology, Inc. (PMT), a medical device innovator focused on improving surgical outcomes for high-risk spine surgery patients, announced that the U.S. Food and Drug Administration (FDA) has cleared its CAVUX® FFS-LX: Lumbar Facet...

03:50
The Centre for Chinese Herbal Medicine Drug Development of Hong Kong Baptist University (HKBU) has developed a new drug using effective components of a Chinese herbal medicine, Chaenomelis Fructus, for the treatment of the rare disease, myofibrillar...


9 january 2024

08:53
LASEROPTEK Co., Ltd., a developer, and manufacturer of world-class lasers for aesthetic and medical dermatology, proudly announces its strategic partnership with The Pinnacle Health Group. This collaboration affirms LASEROPTEK's dedication to...

08:45
Natural Cycles, the leading women's digital health company, announced it has received approval from Health Canada to market and sell the Natural Cycles app as a form of birth control. Previously sold in Canada as a fertility tracker, the Natural...

08:30
Inspira Technologies OXY B.H.N Ltd.  (the "Company" or "Inspira"), a pioneer in life support technology with a vision to supersede traditional mechanical ventilators, today announced its plan to launch a single-use disposable blood oxygenation kit...

08:04
NOWDiagnostics (NOWDx), a developer of over-the-counter and point-of-care (POC) diagnostics tests and first-in-class technology and platforms, today announced they have submitted a De Novo Classification Request to the U.S. Food and Drug...


8 january 2024

12:38
Medtronic plc , a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) approval of its Percepttm RC Deep Brain Stimulation (DBS) system. The rechargeable neurostimulator is the latest innovation in the...

09:00
Shuttle Pharmaceuticals Holdings, Inc. ("Shuttle Pharma") today announced they have received the 'Safe to Proceed' letter from the U.S. Food and Drug Administration (FDA) for the Company's investigational new drug (IND) application for its Phase II...

09:00
Techsomed Medical Technologies LTD is thrilled to announce that FDA has granted De Novo clearance for its BioTraceIO, a groundbreaking ultrasound-based liver ablation software - designed for Tissue Response Prediction. As the first and only...

08:00
Qvintm, the biotechnology research company that developed the first and only healthcare service that collects menstrual blood samples as an alternative to traditionally collected venous blood draws, today announced FDA clearance of its Q-Padtm and...

07:30
Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its SGX945 (dusquetide)...

00:25
Caliway Biopharmaceuticals (Caliway) announced that the United States Food and Drug Administration (U.S. FDA) has accepted the CBL-514 Investigational New Drug (IND) application of CBL-0202 DD Phase 2 Study to treat Dercum's Disease. Dercum's...


5 january 2024

13:35
QDOSE® Multi-purpose Voxel Dosimetry Software (Personalized Dosimetry in Molecular Radiotherapy) received USFDA 510(k) clearance in August 2023. Developed by ABX-CRO (Dresden, Germany) in collaboration with Quantinm AB (Stockholm, Sweden), this...

08:15
Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the submission of a Premarket Approval (PMA) application for its Cordellatm Pulmonary Artery (PA) Sensor...

08:00
ProfoundBio, a clinical-stage biotechnology company developing novel antibody-drug conjugate (ADC) therapeutics for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for rinatabart sesutecan...


4 january 2024

10:00
Orsini Specialty Pharmacy ("Orsini") has been selected by AstraZeneca and Ionis as the exclusive specialty pharmacy partner for WAINUAtm (eplontersen), an FDA-approved treatment for adults living with hereditary transthyretin-mediated amyloid...

08:30
GrayMatters Health (GMH), developer of digital self-neuromodulation therapies for mental health care, announces the official launch of Prism for PTSD in the United States. Prism for PTSD is currently being used to treat patients at two centers, with...

08:22
Accord BioPharma, Inc. the U.S. specialty division of Intas Pharmaceuticals Ltd. focused on development of oncology, immunology, and critical care therapies, announced today the U.S. Food and Drug Administration (FDA) has accepted its Biologics...

08:00
OnQuality Pharmaceuticals ("OnQuality"), a leading targeted oncology supportive therapy company dedicated to addressing unmet needs in oncodermatology and oncogastroenterology to improve the quality of life for patients receiving anticancer...

08:00
Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today the clearance of EDTA blood compatible cartridges by the U.S. Food and Drug Administration (FDA) for use with...

03:30
Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for regenerating bone and managing infection in bone and soft tissue, is pleased to announce that...


3 january 2024

10:00
Geneseeq announced that its multi-cancer early detection solution, CanScantm, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA)....

08:33
Rehabtronics Inc announces it has successfully upgraded its ISO13485:2016 quality certification to include the internationally-recognized Medical Device Single Audit Program (MDSAP) standard. The additional certification confirms the company's...

00:00
AnX Robotica, a pioneering force in advanced gastrointestinal visualization technologies, is excited to announce the FDA clearance of NaviCam ProScantm. Through the rigorous De Novo Submission Process, the FDA has granted clearance for ProScan,...


2 january 2024

08:00
CGBio (CEO Hyun Seung Yu), a Korean company specializing in bio-regenerative medicine, announced on the 2nd that its advanced bone substitute material, "NOVOSIS PUTTY", has been granted 'Breakthrough Device...

07:30
Pulnovo Medical Limited, a globally recognized device pioneer in the treatment of Pulmonary Hypertension (PH) and Heart Failure (HF), recently announced that it has successfully obtained Humanitarian Use Device (HUD) designation from the US FDA and...


28 december 2023

08:45
NeuroBo Pharmaceuticals, Inc. , a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration...

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