Le Lézard

News by subject: FDA

14 december 2018

11:46
The Lupus Research Alliance is pleased to share good news about a potential new treatment for systemic lupus erythematosus (SLE).  Today, Eli Lilly and Company and Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) granted...


13 december 2018

07:00
Check-Cap Ltd. (the "Company" or "Check-Cap") , , a clinical-stage medical diagnostics company offering C-Scan®, the first and only preparation free capsule-based screening method for the prevention of colorectal cancer through the detection of...

06:45
Eli Lilly and Company and Incyte Corporation announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to baricitinib, which is being studied for the treatment of systemic lupus erythematosus (SLE). The...


12 december 2018

08:01
AI diagnostics company IDx spent the first 8 years of its existence operating in stealth mode. But on April 11, 2018, that instantly changed when the company hit the national spotlight after receiving FDA clearance for IDx-DR, an autonomous AI system...


11 december 2018

18:05
Mayne Pharma Group Limited is pleased to announce that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Tolsuratm (SUBA®-itraconazole) 65mg capsules. Tolsura is a new formulation of itraconazole indicated for...

10:30
DBM Corporation, Inc. announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for MIRACU PDO Threads, a huge accomplishment for the company, as it marks the first PDO thread  to receive 510 (k) clearance in...


10 december 2018

21:00
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. "Astellas") today announced that XOSPATA® (generic name: gilteritinib) is now available for prescription in the United States for the treatment of adult patients who have...

15:46
Today, the U.S. Food and Drug Administration cleared a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder (OUD). The...

10:00
The information contained is not intended for distribution in the UK   FDA grants M7824, an investigational bifunctional immunotherapy, orphan drug designation in biliary tract cancer    First regulatory designation for M7824 following recent...

09:00
Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead...

07:00
Alma Lasers, LTD, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a notice of completion from the US Food and Drug Administration (FDA) in response to questions about...


9 december 2018

22:30
Alma Lasers, LTD, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a notice of completion from the US Food and Drug Administration (FDA) in response to questions about...

20:00
TauRx, a leader in neurodegenerative disease research, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to LMTX® for the "treatment of frontotemporal dementia". The term Frontotemporal Dementia...


7 december 2018

07:45
Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Vanguard IEP® Peripheral Balloon Angioplasty System with Integrated Embolic Protection. Contego Medical is a medical device company...


5 december 2018

09:34
Prometic Life Sciences Inc.  ("Prometic" or the "Corporation")...

09:31
Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today FDA approval of its Spiration Valve System (SVS) for the treatment of severe...

08:00
Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Bausch Health Companies Inc. , today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Bausch + Lomb ULTRA®...

07:00
Subtle Medical, a privately-held medical device company focused on improving medical imaging efficiency and patient experience with innovative deep learning imaging technologies, announced today 510(k) clearance from the U.S. Food and Drug...


4 december 2018

19:00
Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, announced today that its IND application for IBI101, a recombinant fully human anti-OX40...

17:00
Alma Lasers, LTD, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a notice of completion from the US Food and Drug Administration (FDA) in response to questions about...

15:00
BioPlus Specialty Pharmacy (BioPlus), a leading innovative specialty pharmacy, is now dispensing the limited distribution oral cancer medication Daurismotm (glasdegib) from Pfizer Inc. The U.S. Food and Drug Administration approved Daurismo on...


3 december 2018

09:49
Notal Vision, Ltd., ("Notal") a privately-held ophthalmic diagnostic services company, focused on advancing eye care by extending ophthalmic disease management from the clinic to the home, has announced the U.S. Food and Drug Administration (FDA)...

09:00
Alma Lasers, LTD, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a notice of completion from the US Food and Drug Administration (FDA) in response to questions about...

08:30
Edwards Lifesciences Corporation , the global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced that the HemoSphere advanced hemodynamic monitoring platform has received U.S. Food and Drug...

08:12
CASI Pharmaceuticals, Inc. , a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in China and throughout the world, announces today that...

08:00
Eiger BioPharmaceuticals, Inc. , focused on the development and commercialization of targeted therapies for rare and ultra-rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND)...

08:00
Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Artificial Intelligence (AI) Pattern Recognition Software, which Bayer is...


29 november 2018

10:18
This new method of contraception could offer an improved bleeding profile and greater flexibility for female population Slinda® has demonstrated that in case of missing a pill, there is no impact in the efficacy during the following 24 hours The...


28 november 2018

19:25
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. "Astellas") today announced that the U.S. Food and Drug Administration (FDA) approved XOSPATA® (generic name: gilteritinib) for the treatment of adult patients who have...

18:20
The U.S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder that affects the connection between nerves and muscles...

14:46
The U.S. Food and Drug Administration today approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The FDA...

13:47
The U.S. Food and Drug Administration today approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin's lymphoma (NHL) to be used as a single agent or...

08:00
Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, announced that its VITROS® Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS® HIV Combo test) received approval from the U.S. Food and Drug Administration for...


27 november 2018

10:00
HighTide Therapeutics Inc., a clinical-stage biopharmaceutical company, announced that the U.S. FDA has granted Fast Track Designation to its investigational new drug, HTD1801, for the treatment of patients with nonalcoholic steatohepatitis (NASH).  ...

08:00
United Orthopedic Corporation, a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instruments, today announced that the U.S. Food and Drug Administration has cleared its vitamin E highly cross-linked...

07:00
Mesa Biotech Inc., is a privately held, molecular diagnostic company that has developed an affordable and easy to operate PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis....


26 november 2018

20:43
The U.S. Food and Drug Administration (FDA) today approved Vitrakvi® (larotrectinib), the first ever oral TRK inhibitor, for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene...

18:41
The U.S. Food and Drug Administration today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker). This is the...

09:01
Perrigo Company plc today announced it has received tentative approval from the U.S. Food and Drug Administration for the first to file generic version of Ultravate® Lotion (halobetasol propionate) 0.05%.  Perrigo previously announced a patent...

09:00
Ultimaker, the global leader in desktop 3D printing, today announced that the Ultimaker S5 has been certified by Materialise as a 3D printing solution to create orthopedic, maxillofacial and cardiovascular models for clinical use when used in...

08:30
Ampio Pharmaceuticals, Inc. today updates the regulatory and peer-review publication status of Ampion. Regulatory update:Statisticians representing Ampio and the FDA met recently to discuss the clinical pathway of...

07:00
Shire Pharma Canada ULC (Shire Canada), the leading global biotechnology company focused on rare diseases, is pleased to announce that on November 21, 2018 Health Canada authorized the extended indication for ADYNOVATE® [Antihemophilic Factor...


22 november 2018

13:32
Medtronic of Canada Ltd., a subsidiary of Medtronic plc announced today that it has received a licence from Health Canada for the Visualasetm MRI-Guided Laser Ablation System. The Visualase system provides advanced MRI-guided laser ablation...


21 november 2018

14:14
AbbVie , a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to VENCLEXTA® (venetoclax tablets) in combination with azacitidine, or decitabine, or...

12:51
The U.S. Food and Drug Administration today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are...

10:00
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for quizartinib for the treatment of adult patients with...

05:00
Sciton, Inc. announced today that the FDA has advised the company that it appears that Sciton has satisfactorily addressed all items raised by the FDA in its July 24, 2018 "It Has Come to Our Attention" letter.  Sciton worked with the FDA in a...

05:00
OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for OBI-888 for the treatment of Pancreatic Cancer. OBI-888 is a first in class monoclonal...


20 november 2018

10:37
The U.S. Food and Drug Administration today approved Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive...

08:00
Pliant Therapeutics, Inc., a biotechnology company focused on discovering, developing and commercializing treatments for fibrotic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the...