Le Lézard

News by subject: FDA

1 march 2023

11:11
A new white paper from the Clinical Neurological Society of America explains how misconceptions about the FDA's Accelerated Drug Approval Program could undermine patients' timely access to novel medications ? and why collaboration and greater...

09:30
Perrigo Company plc , a leading provider of Consumer Self-Care Products, today announced that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Acetaminophen and...

07:30
MediPharm Labs shares progress on clinical trials, including the provision of clinical trial materials and research support to multiple partners.Research support consists of both product and services for partner studies across various...


28 february 2023

16:13
"The Personal Care Products Council (PCPC) is committed to working with the U.S. Food and Drug Administration (FDA) to support its mission to protect consumer health and to understand better how the FDA's proposed reorganization could impact...

15:40
On February 16, The Lancet Neurology published the Phase 3 results of Pfizer's zavegepant for the acute treatment of migraine. The CGRP receptor antagonist nasal spray has met its co-primary endpoints that a single 10mg dose proved to be more...

09:55
Theranica, a prescribed digital therapeutics company developing advanced neuromodulation devices for migraine and other pain conditions, today announced that the Nerivio® prescription wearable recently received Food and Drug Administration (FDA)...

06:45
cultivate(MD) Capital Funds LP, funds that are focused on investments into early-stage healthcare companies with innovative technologies, announced today that one of their portfolio companies, Lincoln, Nebraska-based Virtual Incision Corporation, has...


27 february 2023

07:46
Evofem Biosciences, Inc. today announced that two additional U.S. patents which cover Phexxi® (lactic acid, citric acid and potassium bitartrate) and its labeled indication are now listed in the U.S. Food and Drug Administration (FDA)...


24 february 2023

01:30
Sobi® today announced that the US Food and Drug Administration (FDA) has approved efanesoctocog alfa [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], a first-in-class, high-sustained factor VIII replacement therapy for adults...


23 february 2023

13:04
Convatec today announced it has received clearance from the U.S. Food and Drug Administration for its InnovaMatrix® PD particulate placental extracellular matrix medical device for wound management. FDA clears first-ever...

08:00
Medasense Biometrics Ltd. announced today that  the U.S. Food and Drug Administration (FDA) has granted marketing authorization to the PMD-200 patient monitor with NOL® technology developed for  monitoring nociception (the physiological response to...

08:00
Remilk, a global leader in the development and production of animal-free dairy, announced today it has received both regulatory approval from the Singapore Food Authority (SFA) and a "no questions letter" from the FDA....


22 february 2023

08:00
The United States Food and Drug Administration's (FDA) stance on butter storage is contributing to significant consumer confusion. Our mission at Kitchen Concepts is to eliminate consumer confusion with regards to the safe storage of butter.Since...


21 february 2023

09:41
Expanding Innovations, Inc. (EI), a spinal implant company that designs NON-SCREW based expandable cage technology, announced today that the company has received 510(k) clearance from the FDA for the X-PAC Expandable Lateral Cage System (X-PAC LLIF)....

08:47
Accord Healthcare, Inc., a leading generic pharmaceutical company, has added Lurasidone HCL tablets to its line of generic drugs. Accord's product is AB-rated to Sunovion Pharma's Latuda® and is being offered in 20mg, 40mg, 60mg, 80mg, and 120mg...

08:00
PeekMed® sets new expectations for the orthopedic technology market with the launch of a web-based automated planning solution. With this 510(k) clearance, from the U.S. Food and Drug Administration (FDA), this new advanced AI solution represents a...

07:30
Biohaven Ltd.  announced today that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for taldefgrobep alfa, a novel anti-myostatin adnectin,...

07:00
Chemomab Therapeutics, Ltd. (Chemomab), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced U.S. Food and Drug...

06:50
BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) market approval for the BD Onclaritytm HPV Assay to be used with the ThinPrep® Pap Test....


16 february 2023

18:42
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 and Drug Administration (FDA) has approved...

14:48
Today, Terumo Blood and Cell Technologies announces U.S. Food and Drug Administration (FDA) clearance and official launch of its IMUGARD® WB Platelet Pooling Set, which supports extended shelf life of whole blood-derived platelets from five days to...

03:30
Zephyrus Innovations (Zephyrus), a privately-owned medical device company designing and...


15 february 2023

07:00
FDA provided guidance on opaganib's regulatory pathway under the Animal Rule for Acute Radiation Syndrome (ARS) The FDA's Animal Rule allows for the use of pivotal animal model efficacy studies to support FDA approval of new drugs when human...


14 february 2023

11:57
The FDA has approved the first Non-Covalent (Reversible) BTK (Bruton Tyrosine Kinase) inhibitor for the treatment of Relapsed or Refractory Mantle Cell Lymphoma in adult patients, based on clinical studies conducted with participation by Florida...

08:49
Delcath Systems, Inc. , an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced it submitted a new drug application (NDA) resubmission to the US Food and Drug Administration (FDA) for the...

07:00
Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration for Xpert Mpox, which runs on Cepheid's GeneXpert® systems. The EUA is supported by the Secretary of Health and Human Service's...


13 february 2023

15:22
Guerbet, a global leader in medical imaging with more than 30 years of experience in MRI,...

09:00
HistoSonics, (www.histosonics.com), the developer of a non-invasive platform and novel sonic beam therapy called histotripsy, announced today the US Food and Drug Administration (FDA) has approved the company sponsored #HOPE4KIDNEY Trial which is...

09:00
MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance,...

08:28
Jubilant Therapeutics Inc., a clinical stage biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced that the United States Food and Drug...

07:30
Pharmazz, Inc. ("Pharmazz" or the "Company"), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical...

00:05
Concept Medical Inc. (CMI), on 9th February 2023, received the Investigational Device Exemption (IDE) from the US FDA, for its Magic Touch Sirolimus Coated Balloon....


12 february 2023

19:00
IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, today announced that the U.S. Food and Drug Administration (FDA) has...


10 february 2023

07:07
ProterixBio, Inc. today announced the offering of the Presage® ST2 Assay as a testing service through ProterixBio's high-complexity CLIA laboratory. This Assay has been FDA cleared for use in conjunction with clinical evaluation as an aid in...

02:18
GSK plc (LSE/NYSE: GSK) today reports that the US Food and Drug Administration (FDA) granted full approval for Jemperli (dostarlimab-gxly) for the treatment of adult patients with...


8 february 2023

08:00
Creative Medical Technology Holdings, Inc. , a biotechnology company working to revolutionize care through the development of potentially best-in-class regenerative therapeutics, today announced that it has received Institutional Review Board (IRB)...

06:50
BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced that it has received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for a new molecular diagnostic combination test for...


6 february 2023

10:15
DiA Imaging Analysis, a leading provider of advanced AI-based software solutions for ultrasound image analysis, announced today that the U.S. Food and Drug Administration (FDA) has cleared LVivo IQS, a new AI-based vendor-neutral software solution...

09:12
NeuroSense Therapeutics Ltd. ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced that Health Canada approved the commencement of patient enrollment in Canada for the Company's Phase 2b PARADIGM...

08:10
Hinova Pharmaceuticals Inc., a clinical-stage biopharmaceutical company focusing on developing novel therapeutics for cancers and metabolic diseases, recently announced that the U.S. Food and Drug Administration (FDA) has cleared the company's...

05:00
Inmagene Biopharmaceuticals ("Inmagene") announced that the U.S. Food and Drug Administration (FDA) recently granted the initial investigational new drug (IND) application for its drug candidate IMG-008, a long-acting anti-IL-36R antibody with...


3 february 2023

07:30
Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell...

06:45
Boston Scientific Corporation today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LithoVuetm Elite Single-Use Digital Flexible Ureteroscope System, the first ureteroscope system with the ability to monitor intrarenal...

02:45
Orexo AB (publ.), (STO: ORX) , today announces the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its lead pharmaceutical pipeline asset, OX124, a nasal...


2 february 2023

15:22
VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, today announced FDA approval of its innovative second generation GENOSYL® Inhaled...

13:00
ASPIVIX SA, an innovator and developer of medical technologies to advance gynecological care, today announced that Carevixtm, its novel Cervical Stabilizer, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This next...

12:50
Rosalind Franklin University of Medicine and Science (RFU) announced today that one of its early-stage companies ? Resuscitation Therapeutics (RTx), which is focused on developing new therapies for life-threatening acute cardiovascular events ? is...

11:00
Varian, a Siemens Healthineers company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as CE mark, for Halcyon® and Ethostm radiotherapy systems featuring Varian's HyperSighttm imaging...

09:00
Amgen and AstraZeneca today announced the U.S. Food and Drug Administration (FDA) has approved TEZSPIRE® (tezepelumab-ekko) for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma.1 First...

09:00
Qvintm, the biotechnology company that developed the first and only healthcare service that scientifically collects menstrual blood to test for HR-HPV and other critical healthcare information, announced FDA approval in Thailand for its Q-Pad...