Le Lézard

News by subject: FDA

23 february 2021

09:18
Elicio Therapeutics, a private biotechnology company developing a pipeline of potent immunotherapies based on its proprietary lymph-node targeting Amphiphile technology, announced it has received Investigational New Drug (IND) clearance from the U.S....

09:15
Ampio Pharmaceuticals, Inc. , a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced the addition of two new study sites to further the expansion of its ongoing U.S....

09:00
Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is pleased to announce the 510(k) clearance of the NOVA Lite® DAPI dsDNA Crithidia luciliae (CLIFT) Kit by the US Food and Drug...

08:02
Hoth Therapeutics, Inc. , a biopharmaceutical company, today announced today the successful completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's development plan for their HT-001 product. The...


22 february 2021

13:00
Libtayo was superior in extending overall survival compared to chemotherapy in a pivotal trial that allowed for certain disease characteristics frequently underrepresented in advanced NSCLC trials This is the third approval for Libtayo in the U.S....

12:37
Today, the U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2,...

10:53
Piccolo Medical, Inc. announces that it has received FDA clearance of its SmartPICCtm System. The SmartPICCtm System provides caregivers the ability to navigate peripherally inserted central catheters (PICCs) to the entryway of the heart without...

08:00
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, announced today that its ultrasound enhancing agent (UEA) LUMASON® (sulfur hexafluoride lipid-type A...

07:00
Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, announces U.S. Food and Drug Administration (FDA) conditional Investigational Device Exemption (IDE) approval to commence its pivotal clinical trial called...


18 february 2021

09:00
Medtronic plc , the global leader in medical technology, today announced it has received approval from the United States Food and Drug Administration (FDA) for expanded MRI labeling of its InterStimtm II and InterStimtm Micro sacral neuromodulation...

08:00
FX received their 510k clearance for the Easytech® Stemless Anatomic. It is the only stemless shoulder prosthesis on the market with primary peripheral fixation. The new addition has been long awaited as it has been approved for use in Europe since...

08:00
Astellas Pharma Inc. (TSE: 4503, President and CEO:  Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. today announced completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration...

07:55
Almirall, S.A. (BME:ALM), a global biopharmaceutical company focused on skin health, announced today the U.S. commercial launch of Klisyri® (tirbanibulin), developed for the topical treatment of actinic keratosis (AK) of the face and scalp....


17 february 2021

17:38
Additive Orthopaedics, LLC., announced today it has received an approval order from the U.S. Food and Drug Administration ("FDA") for its Humanitarian Device Exemption ("HDE") application for the Patient Specific Talus Spacer for treatment of...

15:45
Everlywell, a leading digital health company, today announced that the Everlywell COVID-19 Test Home Collection Kit DTC is now available for broad use without a prescription, including purchase by asymptomatic individuals, retailers, pharmacies, and...

14:42
Today, the U.S. Food and Drug Administration approved the Patient Specific Talus Spacer 3D-printed talus implant for humanitarian use. The Patient Specific Talus Spacer is the first in the world and first-of-its-kind implant to replace the talus?the...

09:00
The next generation Scrambler Therapy® Technology ST-5A has received marketing approval from the FDA (K201458). This new device replaces the previous two generations known as "Calmare®" and "Scrambler Therapy® Technology MC-5A" respectively, which...


16 february 2021

16:31
Novartis today announced that the US Food and Drug Administration (FDA) has approved the following expanded indication for Entresto® (sacubitril/valsartan): to reduce the risk of cardiovascular death and hospitalization for heart failure in adult...

16:00
Amgen today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at...

08:00
Forge Biologics Inc., a fully integrated clinical stage gene therapy manufacturing and development company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track, Orphan Drug, and Rare Pediatric Disease (RPD)...

08:00
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit from Thermo Fisher Scientific, the company announced today. The TaqPath COVID-19, Flu A, Flu...

07:00
SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, announced the initiation of commercial and clinical effort in the USA, following issuance of a second FDA clearance for its flagship G-EYE® Colonoscope, based...

06:27
Akan Biosciences, LLC (Akan), a Maryland based, clinical stage biotech company innovating cellular technology and proprietary manufacturing methods to produce stem cell-based therapeutics, today announced that the U.S. Food and Drug Administration...


12 february 2021

17:15
Today, the U.S. Food and Drug Administration approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage...


11 february 2021

14:00
Homozygous familial hypercholesterolemia (HoFH) is an ultra-rare inherited condition that affects approximately 1,300 patients in the U.S. and is characterized by extremely high low-density lipoprotein cholesterol (LDL-C) In pivotal Phase 3 HoFH...

11:23
Acuitive Technologies today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the CITREFIXtm Knotless Suture Anchor System with CITREGENtm material technology, a new generation bioresorbable...

10:17
The Personalized Medicine Coalition (PMC) today released a report documenting the U.S. Food and Drug Administration's approval last year of 19 personalized therapies, one cell-based immunotherapy, and eight significant new diagnostic indications that...

10:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the U.S. Food and Drug Administration (FDA) 510K clearance of stabilised urine samples to be used with the cobas® BKV Test on the cobas® 6800/8800 Systems. This test, previously designated as a...

09:10
Akorn Operating Company LLC (Akorn), a leading specialty pharmaceutical company, announced that it received approval of its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Loteprednol Etabonate Ophthalmic...

09:00
BrainQ, the Israeli start-up with a therapeutic solution to reduce disability following stroke, announced today that the United States Food and Drug Administration (FDA) has designated its AI-powered technology as a Breakthrough Device. The...

08:03
Cerus Endovascular Ltd., a privately-held, commercial-stage medical device company, today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Contour Neurovascular Systemtm....

08:00
LimaCorporate makes important strides in the development of its digital platform designed to assist surgeons in delivering improved outcomes with an accessible and sustainable economic model, following the milestone-based acquisition of TechMah...

07:00
BrainCool AB (publ), a Swedish medical device innovator, and a world leader in medical cooling technology for therapeutic hypothermia (brain cooling) and oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted...


10 february 2021

10:34
Technology and consulting firm, Headspring, received FDA approval of their first product built for the Plasma industry. Developed in partnership with the Protein Plasma Therapeutics Association (PPTA), this new National Donor Deferral Registry &...

10:00
Surgical Planning Associates (SPA) today announced a major step forward in how surgery can be performed with the introduction of its HipInsight augmented reality (AR) intra-operative guidance system for joint arthroplasty. The U.S. Food and Drug...

08:00
Allergan, an AbbVie company, today announced that the U.S. Food and Drug Administration (FDA) has approved BOTOX® for the treatment of detrusor (bladder muscle) overactivity associated with a neurologic condition in pediatric patients 5 years of age...

07:03
Visby Medicaltm announced today the US Food and Drug Administration (FDA) authorized Visby's rapid PCR COVID-19 test for use at the point of care (POC). Building on the FDA's emergency use authorization granted earlier this year, Visby Medical's...


9 february 2021

19:29
The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for investigational bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together, Eli Lilly and Company  announced today. This therapy is...

17:22
Following Priority Review Libtayo receives full approval in locally advanced basal cell carcinoma (BCC) and accelerated approval in metastatic BCC Libtayo now approved for patients with advanced stages of the two most common skin cancers in the U.S....


8 february 2021

10:00
Catapult Therapeutics, a biopharmaceutical company developing novel cancer treatments, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its lead product candidate CAP-100, an...


5 february 2021

15:01
Today, the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least...

12:52
Today, the U.S. Food and Drug Administration authorized marketing of a new prescription only device intended to reduce snoring and mild obstructive sleep apnea. Unlike devices used while patients sleep, this is the first device used while awake that...

08:37
The popular CBD-based sleep aid called 'sleep' by New Phase Blends is about to be released in small, travel sized packaging. These natural sleep aids meet TSA guidelines for flying with CBD products. Millions of American's struggle with the anxiety...


4 february 2021

07:36
Golden Biotechnology Corp.(TPEx:4132)("GoldenBiotech"), a leading Taiwanese biopharmaceutical company, announced that it has made two achievements for its Covid-19 new drug candidate Antroquinonol® (HOCENA®): receiving positive response after DMC...


3 february 2021

15:50
NGMedical, a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application, announces FDA clearance for its purely additively manufactured titanium cervical BEE® cage. The BEE® cage is designed to...

13:43
EMD Serono, the healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that the US Food and Drug Administration (FDA) has approved TEPMETKO® (tepotinib) following Priority Review for the treatment of adult...

09:45
Scientists at the University of Denver have tested a new antibody test for COVID-19 that can predict if a patient will experience mild versus more severe symptoms of the virus. The revolutionary test has received an emergency use authorization from...

09:17
Olympus announced today that it supports the finalized guidance recommendations from the Food and Drug Administration (FDA) indicating that laparoscopic power morcellation in gynecological procedures must be conducted with an approved containment...

09:00
CLEW Medical, a leader in AI-powered predictive analytics, today announced that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance and authorized the use of "CLEWICU," CLEW's artificial intelligence (AI) based ICU solution, to...

09:00
Chengdu Kanghong Pharmaceutical Group ("Kanghong", SHE: 002773), has received Special Protocol Assessments from the Food and Drug Administration for three new indications for its biologic drug conbercept. The drug is an anti-VEGF fusion protein,...