Le Lézard

Communiqués de presse par sujet : Approbation de la FDA (Food and Drug Administration)

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Aujourd'hui

08:00
MEDICALgorithmics, S.A. (WSE: MDG) and U.S. subsidiary Medi-Lynx Cardiac Monitoring L.L.C., today announced that the U.S. Food and Drug Administration  (FDA) has granted 510(k) clearance for the PocketECG Cardiac Rehabilitation System (CRS), a new...

08:00
Allergan plc , a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration has granted Fast Track  designation for AGN-241751, an investigational new treatment for Major Depressive Disorder (MDD).  AGN-241751 is a...

07:30
Amneal Pharmaceuticals, Inc. , a specialty pharmaceutical company, today announced it has received U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application for a generic version of Potassium Chloride oral solution, 20...

06:33
Integrated Device Technology, Inc. (IDT) , announced that its customer Senseonics (Germantown, MD) received FDA approval for its Eversense® Continuous Glucose Monitoring (CGM) System for people with diabetes. The Eversense System consists of an...


20 juillet 2018

11:43
The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class...


19 juillet 2018

09:15
BioPharmX Corporation , a specialty pharmaceutical company developing products for the dermatology market, today announced that the U.S. Food and Drug Administration has waived its requirement for a dermal carcinogenicity study for BPX-01,...


18 juillet 2018

12:59
Novartis today announced a new approval for Kisqali® (ribociclib) from the US Food and Drug Administration (FDA) for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast...

11:17
The U.S. Food and Drug Administration today approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor...

08:00
PainReform Ltd, developer of a proprietary reformulation technology, has received FDA approval to conduct two pivotal Phase III clinical trials for post-operative pain relief in soft and hard tissue. "This green light from the FDA enables us to...

04:00
Advancement of novel inhibitor targeting accumulation of toxic neurofibrillary tau tangles  Asceneuron SA, an emerging leader in the development of innovative small molecules for the treatment of neurodegenerative diseases, announced today that...

04:00
Advancement of novel inhibitor targeting accumulation of toxic neurofibrillary tau tangles  Asceneuron SA, an emerging leader in the development of innovative small molecules for the treatment of neurodegenerative diseases, announced today that...


17 juillet 2018

17:31
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved SYMTUZAtm, the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of human...

15:40
Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products, announced today that it has received 510(k) clearance from the FDA to market Normandy VBR System (Cervical and...

09:01
Candela Corporation, a leading global aesthetic device company, announces the U.S. Food and Drug Administration (FDA) clearance of its Vbeam® Prima, an advanced 595 nm pulsed dye laser (PDL). With the addition of a 1064 nm wavelength and a number of...


16 juillet 2018

08:30
Rockwell Medical, Inc. (the "Company") today provided an update regarding Calcitriol, the Company's FDA approved active vitamin D injection for the management of hypocalcemia in patients undergoing chronic hemodialysis. On July 11, 2018, Rockwell...

08:00
Stryker Corporation announced today that the U.S. Food and Drug Administration has granted pre-market approval (PMA) for the Surpass Streamline Flow Diverter to treat unruptured large and giant wide neck intracranial aneurysms.  The device is the...

07:00
MaxCyte announced that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to begin a clinical study in the United States with its first wholly-owned chimeric antigen receptor (CAR) therapeutic...

02:29
Camurus announced today that the US Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2018 for its investigational weekly and monthly buprenorphine depots, CAM2038, for the treatment of...


13 juillet 2018

15:00
The U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease,...

14:30
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pfizer Inc. today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide),...

14:18
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for the expanded use of its Elecsys® B·R·A·H·M·S PCTtm assay to aid in antibiotic therapy decision making....

01:00
Amgen and UCB (Euronext Brussels: UCB) today announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EVENITYtm* (romosozumab), an investigational monoclonal antibody for the treatment...


12 juillet 2018

11:49
Gilead Sciences...

11:24
Gala Therapeutics (Gala) today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to conduct an Early Feasibility Study (EFS) to examine the safety of the RheOxtm system in subjects...

09:00
Abbott today announced it received approval from the U.S. Food and Drug Administration (FDA) for a next-generation version of its...


11 juillet 2018

08:30
Halozyme Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application from Genentech, a member of the Roche Group, for a subcutaneous (SC) formulation of trastuzumab (Herceptin®) in...


10 juillet 2018

08:00
RedDress Ltd announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RD1 system. RD1 is an innovative wound care product which enables health care providers to produce in real time, in vitro whole...

07:00
Recursion, a biotechnology company that combines artificial intelligence (AI), experimental biology, and automation to discover drugs at scale, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug...

06:47
BioArctic AB (publ) announced today that the company has received approval by Fimea, the Finnish Medicines Agency, and Valvira, the Finnish authority for medical device, as well as the local ethics committee for inclusion of Finnish patients in...


9 juillet 2018

19:00
OBI Pharma, Inc., une société biopharmaceutique taïwanaise (TPEx : 4174), a annoncé aujourd'hui que l'Agence américaine des produits alimentaires et médicamenteux (FDA) des États-Unis a accordé la désignation de médicament orphelin à OBI-3424 pour le...

13:27
La Société Bristol-Myers Squibb Canada (BMS) a annoncé aujourd'hui que l'association immuno-oncologique (I-O) OPDIVO (nivolumab) à...

13:26
Bristol-Myers Squibb Canada Co. (BMS) today announced that immuno-oncology (I-O) combination therapy OPDIVO (nivolumab) 3mg/kg plus YERVOY (ipilimumab) 1mg/kg for intravenous injections, was approved by Health Canada for...

09:00
Oculocare medical Inc., a Swiss technology company, announces today the FDA 510(k) clearance of Alleye®, a mobile medical software application indicated for the detection and monitoring of age-related macular degeneration (AMD). (Logo:...

09:00
Oculocare medical Inc., une entreprise technologique suisse, annonce aujourd'hui qu'elle a reçu l'autorisation 510(k) de la FDA pour Alleye®, une application logicielle médicale mobile indiquée pour la détection et la surveillance de la...

08:49
Companion Medical, a leader in the development of advanced technology to improve diabetes care, has received FDA clearance for the Android version of its InPentm app, clearing the way for release of the first smart pen system for Android users. The...

08:45
Mylan N.V. today announced the U.S. launch of Rivastigmine Transdermal System, 4.6 mg/24 hrs, 9.5 mg/24 hrs and 13.3 mg/24 hrs, a generic version of Novartis' Exelon® Patch. Mylan received final approval from the U.S. Food and Drug Administration...

08:21
Camargo Pharmaceutical Services, LLC, ("Camargo"), the global development and commercialization partner and industry leader utilizing the FDA 505(b)(2) pathway, congratulates US WorldMeds, LLC, on obtaining US Food and Drug Administration (FDA)...

08:00
Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved GAZYVA® (obinutuzumab), in combination with chemotherapy, followed by GAZYVA monotherapy in patients achieving a response, for the treatment of patients with...

08:00
Hoffmann-La Roche Limitée (Roche Canada) a annoncé aujourd'hui que Santé Canada avait approuvé GAZYVA® (obinutuzumab), en association avec une chimiothérapie, suivi de GAZYVA en monothérapie chez les patients obtenant une réponse, pour le traitement...

08:00
? Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. , today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its...

06:59
BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced it has completed the acquisition of TVA Medical, Inc., a company that develops minimally invasive vascular access solutions for patients with chronic...

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-3424 for the Treatment of Hepatocellular Carcinoma (HCC). OBI-3424 is a first in...


5 juillet 2018

21:41
Lipogems, a leader in medical technologies for orthopaedic physicians, announced U.S. Food and Drug Administration (FDA) clearance of the company's Lipogems Microfragmented Adipose Tissue Transplant System.  Federal regulators have cleared the way...


2 juillet 2018

10:31
Shortly after WAT Medical's leading product to treat nausea-induced vomiting, EmeTerm, received its FDA clearance earlier in April, it has now also received official clearance from Health Canada. Health Canada ensures all of its certified medical...

08:30
RiceBran Technologies  ("RBT"), a global leader in the production and marketing of value-added products derived from rice bran, announced today that the Company has received notification that the Food and Drug Administration (FDA) has granted RBT's...

07:05
Compugen Ltd. (CGEN) , a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, was informed that the U.S. Food and Drug Administration (FDA) has cleared Bayer AG's investigational new drug (IND) application for...

07:01
Alkermes plc  today announced that the U.S. Food and Drug Administration (FDA) has approved ARISTADA INITIOtm (aripiprazole lauroxil) for the initiation of ARISTADA® (aripiprazole lauroxil), a long-acting injectable atypical antipsychotic for the...

07:00
Compugen Ltd. , a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on its investigational new drug (IND)...

06:00
Advanced Ingredients® applauds the recent announcement by the U.S. Food and Drug Administration (FDA) to recognize resistant dextrin as a dietary fiber under U.S. Labeling Law. The FDA guidance serves as confirmation of our long-standing position of...

00:49
ReCor Medical announced today that the US Food & Drug Administration approved the Company's new pivotal study of the Paradise Ultrasound Denervation System for the treatment of hypertension: RADIANCE-II. Building upon the recent positive results of...

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