Le Lézard

News by subject: FDA

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13 february 2024

09:00
Edgepark announced today it is offering the newly launched Beta Bionics iLet Bionic Pancreas fully automated insulin delivery (AID) system as part of its comprehensive diabetes management solution portfolio. The iLet is the first and only system that...

08:00
Phase 2 trial, expected to begin in 1H 2024, aims to address the unmet medical need of patients suffering from stage 2 or 3 acute kidney injury with associated acute hypoxemic respiratory failure, a condition associated with a high mortality rate...


12 february 2024

10:37
Tyber Medical LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, has received a U.S. Food and Drug Administration (FDA) 510(k) approval for its Proximal Tibia...

08:45
CymaBay Therapeutics, Inc. , a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA)...

08:00
Proscia®, a leading provider of digital and computational pathology solutions, has received 510(k) clearance from the United States (U.S.) Food and Drug Administration (FDA) for its Concentriq® AP-Dx*. The digital pathology solution was cleared for...


8 february 2024

15:53
Dr. George Waring IV of The Waring Vision Institute (Mt. Pleasant, SC ) will be the first in the nation to perform patient treatments on the just approved TENEOtm Excimer Laser Platform for Myopia and Myopic Astigmatism. "The precise engineering of...

09:00
CH4 Global today issued the following statement regarding the announcement by the U.S. Food and Drug Administration (FDA) that it plans to withdraw a policy that caused multi-year approval delays for certain animal-feed additives that can produce...

08:54
Fresenius Medical Care (FME) receives U.S. Food and Drug Administration (FDA) 510(k) clearance of the company's 5008X Hemodialysis System.This will enable Fresenius Medical Care to offer the industry-leading, high-volume hemodiafiltration (Hv-HDF)...

07:00
Ionis Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Ionis and AstraZeneca's eplontersen, an investigational therapy for the treatment of transthyretin-mediated amyloid...


7 february 2024

10:05
Sibel Health, a leading digital health company, announced today that its continuous wearable monitoring solution, ANNE® One, has received another 510(k) clearance from the U.S. Food and Drug Administration (FDA). The ANNE® One platform now allows for...

03:20
SmartCella, through its business unit ProCella, has been approved by the Swedish Medicinal Product Agency for manufacturing and quality control testing of sterile biological medicinal products for cell therapy. SmartCella is pleased to announce that...


6 february 2024

11:00
Tyber Medical LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, received clearance for the anatomical plating system in Canada. The comprehensive portfolio...

09:15
Zynex, Inc. , an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, today announced that it has received clearance from the U.S....

07:30
StimLabs® announces FDA 510(k) clearance of Corplex P, the pioneering human umbilical cord-derived medical device. This first-of-its-kind clearance marks a significant milestone for the wound care industry and highlights StimLabs' position at its...


5 february 2024

08:00
Vanda Pharmaceuticals Inc. (Vanda) today announced that on February 4, 2024, it received a notification from the U.S. Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA)...

07:00
Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the launch of COMBOGESIC® IV (acetaminophen and ibuprofen) injection in the US....


4 february 2024

19:00
Acepodia (6976:TT), a clinical stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 (??2) T cell platforms to address gaps in cancer care, today announced...


2 february 2024

04:14
Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for RZ-001, for the treatment of...


1 february 2024

09:00
Theradaptive, the market leader in targeted regenerative therapeutics, has gained approval from the U.S. Food and Drug Administration (FDA) for their Investigational Device Exemption (IDE) submission to begin enrolling patients into OASIS, their...

08:01
NeuroBo Pharmaceuticals, Inc. , a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that the U.S. Food and Drug...

04:35
Biosyngen is proud to announce that its latest groundbreaking product, BST02, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of all types of liver cancer, including hepatocellular...


31 january 2024

14:58
By combining years of clinical experience with cutting-edge research and development, IlluminOss Medical announces it has received FDA 510(k) clearance for a new Light-Emitting Diode (LED) Console to speed curing of its patented, light-cured...

09:00
Vanda Pharmaceuticals Inc. (Vanda) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis....

08:00
As part of efforts to continuously improve medical solutions for patients with complex vascular disease, W. L. Gore & Associates, Inc. (Gore) announced recent FDA approval of a lower profile GORE® VIABAHN® VBX Balloon Expandable...

07:00
Labcorp , a global leader of innovative and comprehensive laboratory services, today announced the launch and availability of a new, FDA-cleared blood test for risk...

06:25
Boston Scientific Corporation announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSEtm Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the...


30 january 2024

11:00
Kemin Industries, a global ingredient manufacturer that strives to sustainably transform the quality of life every day for 80 percent of the world with its products and services, conducted extensive research that served as the basis for the U.S. Food...

09:45
Bot Image, Inc., a Nebraska and Maine based Artificial Intelligence medical device company (www.botimageai.com), raised the performance bar with its FDA-cleared AI software ProstatIDtm. The unique trifecta clearance of this software used for prostate...

08:00
IceCure Medical Ltd. ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the U.S. Food and Drug...

06:25
NeoImmuneTech, Inc....


29 january 2024

20:19
Copan Diagnostics, a leader in Clinical Microbiology automation solutions, has announced the third FDA clearance for its innovative pre-analytical processor, Colibrítm. The automated ID/AST preparation instrument is a key component in Copan's full...

19:00
Vanda Pharmaceuticals Inc. (Vanda) today announced that the United States District Court for the District of Columbia granted Vanda's motion for summary judgment on its claim against the United States Food and Drug Administration (FDA) for...

16:15
Halozyme Therapeutics, Inc. ("Halozyme") today announced that Takeda received European Commission (EC) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE® drug delivery technology as maintenance therapy...

14:38
Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell-based therapies, has announced that its sponsor client, CellVax Therapeutics Inc., received clearance of its Investigational New Drug application (IND) by the U.S. Food...

10:00
Tyber Medical, LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity and spine markets, has received a U.S. Food and Drug Administration (FDA) 510(k) approval for a line extension to the...

08:08
Oricell Therapeutics (Oricell), a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for OriCAR-017 for patients with...

07:00
Ascidian Therapeutics, a biotechnology company aspiring to treat human diseases by rewriting RNA, today announced that the U.S. Food and Drug Administration...


25 january 2024

09:00
Abbott announced today that it received approval from the U.S. Food and Drug Administration (FDA)...


24 january 2024

11:05
Enhatch Inc. is excited to announce the U.S. Food and Drug Administration (FDA) 510(k) clearance of a patient specific instrumentation system for Total Knee Arthroplasty. This state-of-the-art system is redefining total knee arthroplasty with its...

10:37
The U.S. Food and Drug Administration has placed a purchase order (75F40123P00369) committing to an annual subscription of digiM I2S, a fully integrated image processing platform based on digiM's proprietary cloud technology. I2S, short for Image to...


23 january 2024

20:00
Heron Therapeutics, Inc. , a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (the "FDA") has approved its supplemental New Drug Application ("NDA") for ZYNRELEF® (bupivacaine and meloxicam)...

09:15
Vanda Pharmaceuticals Inc. (Vanda) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VCA-894A for the treatment of a patient with Charcot-Marie-Tooth disease,...

07:30
Medunik USA, member of Duchesnay Pharmaceutical Group (DPG) one of the few anchor companies selected by the Government of Canada for its Global Hypergrowth Project, is pleased to announce that Pheburane® coverage has reached another important...

05:00
Amadix, a Spanish biotech company, announced today that PreveCol®, its colorectal cancer screening blood test, has received Breakthrough Device Designation from the U.S....

03:12
Solvias, a global provider of chemistry, manufacturing, and control (CMC) analytics, announced today that it will perform analytical release testing services on the world's first CRISPR/Cas9 genome-edited cell therapy. The company has signed a...


22 january 2024

22:53
GC Biopharma Corp. (006280.KS) announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its intracerebroventricular (ICV) Enzyme Replacement Therapy (ERT) candidate, GC1130A, designed for Sanfilippo Syndrome...

11:47
Circulus Holdings, PBLLC ("Circulus"), a producer of post-consumer resin (PCR) from recycled low-density polyethylene, has received a Letter of Non-Objection (LNO) from the U.S. Food and Drug Administration (FDA) for its Ardmore, OK facility....

07:10
On January 17, 2024, NK CellTech Co., Ltd. (NK CellTech), a leading biotech company focused on the development of NK cellular therapies, is pleased to announce that the FDA has granted clearance for the clinical trial of NK010, the non-genetically...


19 january 2024

15:21
Johnson & Johnson...

08:15
Kyverna Therapeutics, Inc. (Kyverna), a patient-centered clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today announced it...

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