Le Lézard

News by subject: FDA

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6 december 2023

07:00
NSite Medical, a leader in scoliosis care and treatment, is excited to announce the FDA clearance of its innovative AI-based Scoliosis Assessment Application. This technological breakthrough signifies a major advancement in scoliosis diagnosis and...

04:00
Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and...

00:18
Approval based on APPLY-PNH trial in adults with PNH and anemia despite prior anti-C5 treatment, and supported by the APPOINT-PNH study in complement inhibitor-naïve patients1-5 In APPLY-PNH, patients who switched to Fabhalta experienced superior...


5 december 2023

18:56
SystImmune, Inc (SystImmune), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) authorized the company to proceed with the planned clinical study of the HER2-specific HIRE platform ADC, BL-M07D1,...

16:01
Company Today Also Provided Updates on R&D Portfolio and Strategy at Investor Event Crinecerfont New Drug Application Submission Planned in 2024NBI-'770, an Oral NMDA NR2B Negative Allosteric Modulator, Entering Phase 2 for the Treatment of Major...

09:27
ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced imageable embolic therapies, announces its Eye90 microspheres device has been granted Breakthrough Device...

08:00
Octapharma USA announced the expansion of the U.S. Food and Drug Administration (FDA) approval for wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection. The approved label...


4 december 2023

18:00
Vanda Pharmaceuticals Inc. (Vanda) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of Vanda's New Drug Application (NDA) for tradipitant for the treatment of symptoms of gastroparesis....

16:30
Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted TAR-200 Breakthrough Therapy Designation (BTD) for the potential future treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk...

15:00
West Pharmaceutical Services, Inc. , a global leader in innovative solutions for injectable drug administration systems, today announced FDA 510(k) clearance and launch of its Vial2Bag Advanced® 13mm admixture device....

11:00
Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance (NOC) for LITFULOtm (ritlecitinib). A once-daily oral treatment, LITFULO is the first and only treatment approved by Health Canada for individuals 12 years of age...


1 december 2023

17:22
Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) approved Jaypirca® (pirtobrutinib,...


30 november 2023

09:57
Alafair Biosciences announced today that VersaWrap has received 510(k) clearance from the FDA, enabling application of VersaWrap in all populations, regardless of age. The additional clearance allows pediatric surgeons and facilities the flexibility...

07:03
Transit Scientific, a Utah-based medical device company specializing in innovative solutions for vascular procedures, has announced the FDA clearance of its microcatheter designed for the precise delivery of a broad range of embolic agents. This...


28 november 2023

11:22
Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS)?two related blood diseases that disproportionally strike older adults?are notoriously difficult to treat and associated with high relapse rates. Although new therapies have improved...

10:00
Accorto Regulatory Solutions, LLC. (Accorto), a US-based regulatory firm specializing in helping small to mid-sized companies navigate the regulatory landscape to bring their FDA-regulated products to market, and Inter Scientific Ltd., an...

07:00
Carisma Therapeutics Inc. ("Carisma" or the "Company"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced the clearance of its Investigational New Drug application (IND) by...

07:00
Inflammatix, Inc., a pioneering molecular diagnostics company, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company's lead product, the TriVeritytm Acute Infection and Sepsis Test...


27 november 2023

18:03
Today, the U.S. Food and Drug Administration approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with...

09:00
Neurelis, Inc., a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical need, announced that it has secured the issuance...

08:33
BrainSpec, the comprehensive software platform enabling virtual biopsies of the brain, has been awarded clearance by the...

08:00
AWAK Technologies (AWAK), a pioneering medical technology company developing a wearable dialysis product and other complementary solutions for chronic kidney disease (CKD) management, today announced that its kidney disease progression prediction...

07:00
RTI Surgical, a leading global medical device organization, announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for a clinical study designed to confirm the safety and effectiveness...


23 november 2023

08:02
Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announces today that the US Food and Drug Administration (FDA) has granted...


22 november 2023

18:30
The "FDA Inspections and Audit Readiness Course" training has been added to  ResearchAndMarkets.com's offering. This seminar is broken into two phases. Phase one corresponding to Day 1 will build basic knowledge of the inspection - the who, what,...

13:01
4DMedical, the leading producer of advanced lung function imaging software has received FDA clearance for its CT-based ventilation product (CT LVAStm). CT LVAS, designed for use with computed tomography...

08:00
Albumedix Ltd ('Albumedix'), now part of the life science group Sartorius, announces that Recombumin® is critical to the manufacture of the first FDA- licensed chikungunya vaccine. Valneva's lyophilized chikungunya vaccine IXCHIQ® is the first in...

04:22
Brainomix, the AI-powered medtech solutions company, has heralded its continued US expansion with the launch of its full suite of FDA-cleared modules in its...

03:30
Albumedix Ltd ('Albumedix'), now part of the life science group Sartorius, announces that Recombumin® is critical to the manufacture of the first FDA- licensed chikungunya vaccine. Valneva's lyophilized chikungunya vaccine IXCHIQ® is the first in...


21 november 2023

17:00
Baird Medical Devices, Inc. ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China, today announced that its subsidiary, Betters (Suzhou) Medical Co., Ltd, has received clearance from...

10:09
MIRA Pharmaceuticals, Inc. ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company, today revealed groundbreaking insights into the cognitively enhancing effects of MIRA1a in normal mice during a presentation at the...

07:00
Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced today that U.S. Food and Drug Administration has approved its Phase II IND...


20 november 2023

11:03
Pixyl has announced FDA 510(k) clearance for Pixyl.Neurotm, the next-generation AI software for brain MRI analysis that recently demonstrated enhanced detection rates up to 28%1. Pixyl is an award-winning French medtech specializing in AI-powered...

06:19
NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration...


17 november 2023

18:30
Medtronic plc , a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Symplicity Spyraltm renal denervation (RDN) system, also known as...

10:19
Takeda (TSE:4502/NYSE:TAK) today announced the European Commission has approved TAKHZYRO® (lanadelumab) for the routine prevention of recurrent attacks of...


16 november 2023

22:33
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. today announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for...

11:13
The US Food and Drug Administration (FDA) has granted over-the-counter marketing clearance for the ManaFlexx 2®, an Electrical Stimulation (EMS) device, from MANAMED®, LLC. ManaFlexx 2 is a compact medical device that delivers electrical pulses to...

11:00
The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have approved Kanna Health's Investigational New Drug (IND) application and Clinical Trial Application (CTA), respectively, to start...

08:00
Lighthouse Pharmaceuticals, a clinical-stage biopharmaceutical company pioneering precision medicine for the treatment of Alzheimer's and other diseases of aging, today announced clearance by the U.S. Food and Drug Administration (FDA) of the...

07:30
Ad Astra Diagnostics (AAD), developer of rapid diagnostic systems, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its QScouttm rapid-result hematology...

04:04
Versameb AG ("Versameb"), a pre-clinical stage company focused on transforming RNA therapeutics to treat unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application...


15 november 2023

07:00
Chemomab Therapeutics Ltd. (Chemomab), a clinical stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory...


13 november 2023

13:05
Brixton Biosciences, a clinical-stage life sciences company developing novel therapies for chronic and acute pain, is delighted to announce that its groundbreaking Cooliotm Therapy has received the prestigious Breakthrough Device Designation from the...

10:00
InMed.AI (InMed Prognostics Inc.), a pioneer in AI-driven predictive analytics using multi-modal data including text, signal, and image (US Patent No.11263749) and the creator of an end-to-end fully automated organ agnostic imaging platform,...

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 submitted a 510(k) application to...

09:00
Karmanos Cancer Institute, the largest provider of cancer care and research in Michigan and part of McLaren Health Care, announced today that it will be the first provider in the country to offer patients the new FDA-approved TheraBionic P1 device...

09:00
Kyverna Therapeutics, Inc. (Kyverna), a patient-centered clinical-stage biopharmaceutical company focused on developing cell therapies...

08:15
Neurent Medical, a company pioneering innovative non-surgical interventions to treat chronic inflammatory sinonasal diseases, today announced a significant milestone for the chronic rhinitis market. The Centers for Medicare and Medicaid Services...


10 november 2023

08:00
Lipella Pharmaceuticals Inc. , a clinical stage pharmaceutical company addressing serious diseases with significant unmet need based in Pittsburgh, PA, announced today that it has been granted "Orphan Drug Designation" from the U.S. Food...

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