Le Lézard

News by subject: FDA

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10 november 2023

07:45
Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, announced today that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for RZ-001, for...


9 november 2023

17:35
Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus. The chikungunya virus is primarily...

14:57
Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter antigen test for COVID-19. ACON Laboratories' Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home...

08:32
BioCare today released a white paper on the Drug Supply Chain Security Act (DSCSA) and how companies can prepare for compliance with the U.S. Food and Drug Administration's (FDA) requirements to ensure all medications are genuine, uncontaminated, and...

08:30
MediView XR, Inc., a leading clinical augmented reality (AR) med-tech company, announced today the first inpatient utilization of its XR90 AR-based surgical visualization and navigation system since its 510(k) clearance from the U.S. Food and Drug...


8 november 2023

12:51
Ascidian Therapeutics,...

12:46
Today, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity (body mass index of 30 kilograms per square meter (kg/ m2) or greater) or overweight (body mass index of 27...

12:22
The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company's Zepboundtm (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP (glucose-dependent...

08:10
Recor Medical, Inc. ("Recor") and its parent company, Otsuka Medical Devices Co., Ltd. ("Otsuka Medical Devices") today announced the U.S. Food and Drug Administration (FDA) has approved Recor's Paradisetm Ultrasound Renal Denervation (RDN) system...


7 november 2023

13:02
Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), today announced that PPMD has provided $250,000 in funding to Rare Disease Research, LLC (RDR), to open a second...

08:00
Hoag Memorial Hospital Presbyterian announced the successful implant of the world's first dual chamber leadless pacemaker in a patient. The minimally invasive surgery was a success and marks a new era in cardiac care....


6 november 2023

09:58
Smileyscope has made history by becoming the first virtual reality (VR) device to receive FDA Class II clearance for acute pain. This approval recognizes Smileyscope's innovative Procedural Choreographytm technique, which uses positive virtual...


4 november 2023

20:00
On October 26, 2023, KangaBio announced that the U.S. FDA has granted official approval for their independent R&D clinical trial application (IND) for KGX101. KGX101 is a recombinant IL-12 Fc fusion protein designed for intravenous injection. The...


3 november 2023

08:02
POLARISAR is pleased to announce today that their STELLAR Knee has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). STELLAR Knee is the first clearance for POLARISAR, a company focused on creating a new category in Mixed...


2 november 2023

09:51
Empatica, a digital health and AI company developing medical-grade wearables and digital biomarkers for health monitoring and diagnostics, today announced US Food and Drug Administration (FDA) 510(k) clearance for two new digital biomarkers for its...

09:00
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31 october 2023

18:43
Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following...

16:57
Novartis,...

16:55
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Monday, the FDA provided an update from our ongoing postmarket evaluation of Essure by posting interim results from the postmarket...

08:36
Orphan Drug Designation (ODD) is a status that provides 7 years of post-approval protection and exemption from filing feesRare Pediatric Disease Designation (RPDD) qualified the Sponsor at the time of registration for a salable, transferable priority...

07:00
Chimeric Therapeutics , an Australian leader in cell therapy, announced today that the U.S....


30 october 2023

11:00
Signifying a monumental step forward in the domain of powered antibody therapies, SparX Biopharmaceutical Corp. proudly announces that its Investigational New Drug (IND) application for SPX-303, a First-in-Class anti-LILRB2/PD-L1 bispecific antibody...

09:00
NeuroTrigger is pleased to announce that its non-invasive muscle stimulation system (NTB) has been granted 510(k) clearance by the US Food & Drug Administration (FDA) for the prevention or retardation of disuse atrophy and muscle re-education to...

04:01
Integrum (publ) today announces that the company's OPRAtm Implant system is approved by FDA to be used in a clinical study on below-knee amputations in the US. The clinical study will be important for the future approval of the OPRAtm Implant...


27 october 2023

10:00
Global biotechnology leader CSL and uniQure N.V. , a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the companies have received the 2023 Prix Galien USA Award in the...


26 october 2023

19:11
Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), welcomed today's decision by the Food and Drug Administration (FDA) to approve AGAMREE® (vamorolone) a dissociative...

18:24
Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved Omvohtm (mirikizumab-mrkz) infusion...

09:00
Centinel Spine®, LLC, ("the Company")...

08:00
Cordance Medical, a pioneering medical device company focused on opening the Blood-Brain Barrier (BBB) to facilitate liquid biopsy, announces that its NeuroAccesstm device has been granted Breakthrough Device Designation by the U.S. Food and Drug...

08:00
RoadMap Technologies, a leading provider of data science and software solutions for the Life Sciences industry, today announced that RoadMap has expanded its HITRUST certified platform to support JSON-based De-identification, as well as FDA Clinical...

06:48
NRx Pharmaceuticals, Inc. ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company today announced further alignment...

06:11
EOSolutions Corp. is thrilled to announce that the US Food and Drug Administration (FDA) has cleared the Thinline Introducer Sheath, a remarkable achievement swiftly following the successful launch of the revolutionary Dr. Banner Balloon Guide...

05:57
On October 26, 2023, Biosyngen's TIL therapy BST02 for liver cancer was granted an approval for clinical trial by the US FDA. BST02, a breakthrough product in the field of cell and gene therapy, represents the world's first TIL therapy designed for...

05:38
As the first hearing aid manufacturer to be listed in China, JINGHAO MEDICAL has once again taken a historic step. On September 26, 2023, the self-fitting OTC hearing aid developed and manufactured by JINGHAO MEDICAL officially received FDA 510K...


25 october 2023

11:37
Denti.AI, a pioneer in leveraging Artificial Intelligence for dental pathology detection, odontogram and periodontal charting automation, proudly announces the 510(k) clearance by the FDA of its innovative product, Denti.AI...

08:30
Akebia Therapeutics®, Inc. , a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the U.S. Food and Drug Administration (FDA) has acknowledged that the resubmission to its New Drug...

08:11
Ventric Health, a healthcare technology company and medical device provider focused on cardiovascular health, today announced that its medical device, the Vivio Systemtm, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA)....


24 october 2023

16:08
Today, the U.S. Food and Drug Administration approved Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an...

15:29
Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced the U.S. Food and Drug Administration (FDA) has approved TIBSOVO® (ivosidenib tablets) for the treatment of patients with...

09:33
Petoskey Plastics has received a No Objection Letter (NOL) from the U.S. Food and Drug Administration (FDA) confirming the capability of its secondary recycling process to produce post-consumer recycled linear, low-density polyethylene (PCR-LLDPE)...

09:00
Medinol today announced United States Food and Drug Administration (FDA) approval for the EluNIR-PERLtm drug-eluting stent (DES) for the treatment of coronary artery disease....

07:00
Submission seeks approval for treatment of an abnormal heart rhythm, Paroxysmal Supraventricular Tachycardia or PSVTComprehensive data package includes positive results from pivotal Phase 3 RAPID trial which Company believes demonstrates new calcium...

03:05
BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "BioRay") announced on October 7th that its clinical trial application for BR105 Injection has received approval from the United States Food and Drug Administration (FDA). This marks...


23 october 2023

12:00
THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINItm Miniature Robotic System has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with implants from...

09:50
USA News Group - Despite being a relatively rare form of cancer, pancreatic cancer remains one of the deadliest in the oncology field, the third leading cause of cancer death in the USA. Still not fully understood, pancreatic cancer's 5-year survival...

09:30
Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for...

09:00
VUNO Inc., South Korean medical AI company has received 510(k) clearance from the Food and Drug Administration (FDA) for its AI-powered brain quantification device, VUNO Med®-DeepBrain®. VUNO Med®-DeepBrain® is intended to automate the current...

08:00
Medtronic plc , a global leader in healthcare technology, has received U.S. Food and Drug Administration (FDA) approval for the Aurora EV-ICDtm MRI SureScantm (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EVtm MRI SureScantm...

06:01
As the first hearing aid manufacturer to be listed in China, JINGHAO MEDICAL has once again taken a historic step. On September 26, 2023, the self-fitting OTC hearing aid developed and manufactured by JINGHAO MEDICAL officially received FDA 510K...

05:00
cultivate(MD) Capital Funds LP, funds that are focused on investments into early-stage medical device companies with innovative technologies, announced today that one of their portfolio companies, St. Louis, Missouri-based SentiAR, Inc., a pioneer in...

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