Le Lézard

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

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1 août 2018

08:41
EAS Consulting Group, LLC: The Good Manufacturing Practices (GMPs) dictated in 21 CFR 111 have been in place for over a decade, but the FDA continues to issue numerous Warning Letters to the industry for a failure to comply with even the basic...

08:00
Medtronic du Canada ltée, une filiale de Medtronic plc a annoncé aujourd'hui qu'elle a obtenu de Santé Canada l'homologation de sa plateforme IntellisMC, qui comprend le plus petit stimulateur de moelle épinière implantable au monde pour le...

08:00
Medtronic of Canada Ltd., a subsidiary of Medtronic plc today announced it has received a licence from Health Canada for its Intellistm platform, which includes the world's smallest implantable spinal cord stimulator (SCS) for the management of...

08:00
- Quizartinib has received FDA Breakthrough Therapy designation in patients with relapsed/refractory FLT3-ITD AML, a very aggressive form of the disease associated with poor prognosis - Significant unmet medical need exists in relapsed/refractory...


31 juillet 2018

11:00
Aerin Medical, Inc. ("Aerin") announced that over 1,000 patients suffering from nasal obstruction have successfully received the VIVAER® Nasal Airway Remodeling treatment ("VIVAER") which uses patented non-invasive low temperature radio frequency...

06:00
United Therapeutics Corporation today announced approval by the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for the use of Remodulin (treprostinil) Injection in the Implantable System for Remodulin® (ISR). The ISR has...


30 juillet 2018

15:31
The U.S. Food and Drug Administration today approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that...

13:00
Sekisui Diagnostics announces the FDA clearance of their SEKURE® HbA1c assay.   The assay has been cleared to be used as an aid in the diagnosis of diabetes mellitus, as an aid in identification of patients at risk for development of diabetes...

13:00
Sekisui Diagnostics annonce avoir obtenu l'autorisation de la FDA (l'agence américaine des produits alimentaires et médicamenteux) pour leur test SEKURE® HbA1c. Le test a été autorisé pour utilisation comme une aide dans le diagnostic du diabète...

10:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received U.S. Food and Drug Administration (FDA) approval for the cobas® HPV Test to be used as the first-line screening test for cervical cancer in women 25 and older using cervical...

08:00
DURECT Corporation today announced that Indivior PLC (LON: INDV) has reported that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for PERSERIStm (risperidone), which was formerly known as RBP-7000.  As...

06:00
Cladribine tablets is an investigational oral therapy with proposed dosing of a maximum of 20 days over two years with no additional dosing required in years 3 and 4  The New Drug Application includes close to 12,000 patient years of data and up to...

00:51
CStone Pharmaceuticals (CStone) today announced that its IND application for CS3006, a small-molecule inhibitor of mitogen-activated protein kinase (MEK), has been approved by the China National Drug Administration (CNDA) for clinical trials, just 3...


27 juillet 2018

19:44
Indivior PLC (LON: INDV) today announced that the U.S. Food and Drug Administration (FDA) has approved PERSERIStm, the first once-monthly subcutaneous risperidone-containing, long-acting injectable (LAI) for the treatment of schizophrenia in adults....

13:00
Abbott today announced that the U.S. Food and Drug Administration (FDA) has approved the FreeStyle® Libre 14 day Flash Glucose Monitoring system, which allows people with diabetes to wear the sensor up to 14 days with high accuracy. This approval...

11:50
CIVCO Radiotherapy, the leading global provider of high quality, innovative, patient-centric radiotherapy solutions and Adaptiiv (formerly 3D Bolus), the definitive 3D technology platform for radiation therapy, are excited to announce 510(k)...

08:30
NuVasive, Inc. , the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Pulsetm surgical automation platform has received 510(k) clearance...

07:05
BloodCenter of Wisconsin's Diagnostic Laboratories, part of Versiti, is the first to offer the Abbott RealTime IDH1 assay that identifies specific gene mutations in patients with acute myeloid leukemia (AML). BloodCenter's new offering, which follows...


26 juillet 2018

09:33
CarboFix Orthopedics LTD., is pleased to announce that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for the CarboClear® Carbon Fiber Pedicle Screw System, a novel device to surgically treat oncological patients in the United...

08:00
Flashback Technologies, Inc. has been granted 510(k) clearance by the U.S. FDA for the CipherOx® CRI M1 monitor, a handheld device that noninvasively calculates and displays heart rate, SpO2 and the Compensatory Reserve Index (CRI). CRI is a...

07:00
Cepheid announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the Xpert® Xpress Flu/RSV test. The test can be performed in near-patient settings,...


25 juillet 2018

23:19
Innovent Biologics, a world-class China-based biopharmaceutical company that develops and intends to commercialize high quality innovative antibody-based therapeutics, today announced that it has received Investigational New Drug (IND) approval from...

13:01
INSIGHTEC®, a global medical technology innovator of incisionless surgery, today announced that the U.S. Food and Drug Administration (FDA) has approved the initiation of a clinical study using the company's MR-guided Focused Ultrasound (MRgFUS) to...

09:00
Approval Helps Healthy.io Usher in Era of Medical Selfie, Leveraging Embedded Smartphone Cameras to Improve Patient Adherence and Outcomes and Curb Healthcare Expenditures   Healthy.io, the first company in the world to enable the...


24 juillet 2018

16:29
The U.S. Food and Drug Administration today approved a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The Magtrace and Sentimag Magnetic Localization System (Sentimag System) uses magnetic...

08:30
AbbVie , a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. , announced that the U.S. Food and Drug Administration (FDA) approved ORILISSAtm (elagolix), the first and only oral gonadotropin-releasing...


23 juillet 2018

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...

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