Le Lézard

News by subject: FDA

5 july 2023

08:00
Poseida Therapeutics, Inc. , a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its...


3 july 2023

07:00
Skyline Therapeutics, an innovation-driven gene therapy company committed to developing unique and novel solutions for rare and severe diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug...


1 july 2023

21:00
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 BL-B01D1 in the Investigational New Drug (IND)...


29 june 2023

20:07
ARUP Laboratories today announced that the U.S. Food and Drug Administration (FDA) has approved AAV5 DetectCDxtm as a companion diagnostic to aid in the selection of adult patients eligible for treatment with ROCTAVIANtm (valoctocogene...

18:20
Today, the U.S. Food and Drug Administration approved Roctavian, an adeno-associated virus vector-based gene therapy for the treatment of adults with severe hemophilia A without pre-existing antibodies to adeno-associated virus serotype 5 detected by...

14:34
BioMarin...

13:34
Moderna, Inc. , a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has initiated the filing of a rolling New Drug Submission (NDS) to Health Canada for its updated monovalent COVID-19...

08:00
Cresilon, Inc. ("Cresilon"), a Brooklyn-based biotechnology company focused on hemostatic medical device technologies, today announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for Cresilon...


28 june 2023

18:22
Today, the U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is approved for the treatment of...

10:47
Candela Corporation (Candela), a leading global medical aesthetic device company headquartered in Marlborough, MA, today announced that the Vbeam Family of Pulsed Dye Lasers (PDL) has expanded its FDA cleared indications for use of the 595 nm...

09:01
Overjet, the dental industry leader in artificial intelligence, announced today its fourth FDA clearance, expanding the use of its AI technology for predicting tooth decay in younger patients....

08:35
Genprex, Inc. ("Genprex" or the "Company") , a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast...


27 june 2023

14:40
Ascendia Pharmaceuticals CEO Jim Huang, Ph.D. announces Ascendia's patented EmulSol® nanotechnology has been used to develop a novel nanoemulsion IV formulation for clopidogrel that has received Investigational New Drug (IND) approval from the Food &...

09:14
NovaBone Products, leaders in synthetic biologics is pleased to announce the company has received clearance from the U.S. Food and Drug Administration (FDA) for its proprietary Wound Matrix product ? first of its kind collagen + 45S5 bioactive glass...

09:03
The Elecsys® tTau/Abeta42 ratio helps clinicians define Alzheimer's disease (AD) biologically and expands Roche's AD CSF portfolio to include biomarkers for all three main pathological processes of Alzheimer's: amyloid plaques, tau tangles and...

07:00
FDA approval of RYSTIGGO® (rozanolixizumab-noli) has been granted under the Priority Review designation for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific...

07:00
Alcyone Therapeutics Inc. (Alcyone), a biotechnology company pioneering next-generation precision genetic...


26 june 2023

09:00
ATCOR Medical, subsidiary of CardieX and developer of innovative medical devices and digital solutions to personalize healthcare and improve clinical trial patient outcomes, today announces it has entered into a partnership agreement with Datacubed...

08:00
Corium, LLC, a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today that the peer-reviewed journal Frontiers in Psychiatry published an analysis of a...

07:00
MEDICAL IP (CEO Joon S. Park), an AI-based digital twin company, announced that CT-based automatic body composition...

03:00
Escala Medical Ltd., proudly announces its selection as a recipient of a ?5.5 million in grant and equity investment from the European Innovation Council.  Escala is at the forefront of the pelvic organ prolapse (POP) treatment revolution....


23 june 2023

08:30
ImageBiopsy Lab announced it has received clearance from the United States Food and Drug Administration (FDA) for IB Lab LAMA, the first fully-automated radiological image processing software for geometric length and angle measurements of the lower...

08:10
CMP Pharma, Inc. announced today that Atorvaliq (atorvastatin calcium) Oral Suspension, 20 mg/5 mL, the first and only FDA-approved oral liquid of atorvastatin, is now available. Atorvaliq is a ready-made liquid oral suspension of atorvastatin...

07:00
CULT Food Science Corp. ("CULT" or the "Company") (FRA: LN0), a pioneer in the investment, development, and commercialization of cellular agriculture technologies and products, announces that GOOD Meat, the cultivated meat division of CULT's...


22 june 2023

17:11
ZEISS is now offering customers validation solutions for their ZEISS Coordinate Measuring Machines (CMMs). The validation of quality assurance systems is essential for complying with the requirements of regulated industries. Customers can now speed...

16:06
Sebela Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) granted approval of SUFLAVEtm (polyethylene glycol, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution), for colonoscopy...

15:33
Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), heralded today's decision by the Food and Drug Administration (FDA) to approve the first-ever U.S. application for a...

14:46
Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who do not have a...

08:32
Caristo Diagnostics Limited, a global leader in cardiac and vascular disease diagnostics and risk prediction, applauds the FDA's decision to approve colchicine as first anti-inflammatory drug for cardiovascular disease. Caristo reaffirms its...

08:05
Eyenuk, a global artificial intelligence (AI) digital health company, and the leader in real-world...

06:15
Haemonetics Corporation , a global medical technology company focused on delivering innovative solutions to drive better patient outcomes, today announced it has received clearance from the?U.S. Food and Drug Administration?(FDA) for advancements to...


21 june 2023

16:55
VVT Medical, a global medical device company, announces today the receipt of a 510(k) clearance for its ScleroSafetm platform by the U.S. Food and Drug Administration (FDA)....

13:15
The U.S. Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes, Boehringer Ingelheim and Eli Lilly...

12:45
Dr. PRP USA LLC has secured 510K clearance from the FDA for its Platelet Rich Plasma (PRP) kits. This approval allows for broader distribution and utilization of its PRP kits within the medical industry. The PRP therapy, recognized for its...

11:42
UPSIDE Foods makes history after completing the final step in the U.S. pre-market regulatory review process for cultivated meat by obtaining a Grant of Inspection from the United States Department of Agriculture (USDA) for its cultivated chicken....

09:00
Mediso has announced the Food and Drug Administration (FDA) clearance of the InterViewtm FUSION and InterViewtm XP multimodality (PET/SPECT/MRI/CT) image processing and reporting software which is specifically adapted for nuclear medicine and...

09:00
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) for the treatment of adults and pediatric patients with CD19-positive B-cell...

08:10
CMP Pharma, Inc. announced today that Liqrev (Sildenafil) Oral Suspension, 10 mg/mL, the first and only FDA-approved ready-made oral liquid of sildenafil, is now available. Liqrev is a liquid oral suspension of sildenafil formulated for patients with...

07:05
Teikoku Pharma USA, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for TPU-006 in managing postoperative pain. TPU-006 is an investigational 4-day dexmedetomidine...

07:05
Metavention, Inc. has received US Food & Drug Administration (FDA) approval to initiate its RADAR Pivotal IDE study to determine the safety and efficacy of their Integrated Radio Frequency (iRF) Renal Denervation System, for the treatment of...

04:00
Mediso has announced the Food and Drug Administration (FDA) clearance of the InterViewtm FUSION and InterViewtm XP multimodality (PET/SPECT/MRI/CT) image processing and reporting software which is specifically adapted for nuclear medicine and...


20 june 2023

18:30
Halozyme Therapeutics, Inc. ("Halozyme") today announced that argenx received U.S. Food and Drug Administration (FDA) approval for VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection with ENHANZE® for subcutaneous (SC) use for the...

18:16
Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2...

10:00
Aardvark Therapeutics, Inc., a clinical stage biopharmaceutical company, today reported receipt of an Orphan Drug Designation from the FDA for its lead program, ARD-101, an oral...

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 the FDA (Food and Drug Administration)...

07:30
Precigen, Inc. , a biopharmaceutical company specializing in the...

07:00
Global biotechnology leader CSL Behring today announced that the first patient has received U.S. Food and Drug...

06:00
Premia Spine, a medical technology company revolutionizing the treatment of chronic leg and back pain, proudly announces the Food and Drug Administration (FDA) approval of its Total Posterior Spine (TOPS) facet joint replacement system. The TOPS...


17 june 2023

08:49
IASO Biotechnology ("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...


16 june 2023

13:12
Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), announced the expansion of its renowned Certified Duchenne Care Center (CDCC) Program with the certification at Boston...