Le Lézard

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

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8 août 2018

15:00
BALTIMORE, Aug. 8, 2018 /PRNewswire-PRWeb/ -- Maryland Dermatology Laser Skin & Vein Institute is pleased to report the recent FDA approval of Restylane Lyft for the treatment of wrinkles and volume deficiencies in the hands. With age, hyaluronic...

13:21
The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior...

12:32
CSTAR Cannabis Inc. ("CSTAR Cannabis") is pleased to announce that its application to become a Licensed Producer ("LP") under Health Canada's Access to Cannabis for Medical Purposes Regulations ("ACMPR") has progressed to the 'Active Review' Stage....

12:16
Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces today that the U.S. Food and Drug Administration (FDA) has granted approval for Poteligeo® (mogamulizumab-kpkc) for the treatment of adult patients with relapsed or refractory mycosis fungoides...

12:16
The U.S. Food and Drug Administration today approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway was created to expedite the...

09:00
Aidoc, a leading provider of AI solutions for radiologists announced today that it was granted Food and Drug Administration (FDA) clearance for the first product of its expanding suite of AI-based workflow optimization solutions. The clearance is for...

07:30
REGENXBIO Inc. , a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced financial results for the quarter ended June...


7 août 2018

10:00
Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food & Drug Administration (FDA) has accepted for review the company's New Drug Application for its leading respiratory pipeline candidate Ryaltristm (rye - al'...

07:30
Lipocine Inc. , a specialty pharmaceutical company, today announced financial results for the three and six months ended June 30, 2018. Second Quarter and Recent Corporate Highlights Received a Complete Response Letter...

07:00
Prometic Sciences de la Vie Inc. (« Prometic ») a annoncé aujourd'hui avoir obtenu une désignation de maladie pédiatrique rare de la Food and Drug Administration (FDA) américaine pour son médicament candidat à base de petite molécule, le...

07:00
Prometic Life Sciences Inc.  ("Prometic") today announced that the U.S. Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Designation to its small molecule drug candidate, PBI-4050, for the treatment of Alström syndrome (AS)....


3 août 2018

08:00
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to lurbinectedin for the treatment of small cell lung cancer (SCLC)  SCLC is a very aggressive cancer, about 18% of all the lung cancer cases diagnosed are SCLC, and...


2 août 2018

16:02
Hologic, Inc. announced today that it has received FDA clearance for its Group B Streptococcus (GBS) assay on the Panther Fusion® system. GBS is a bacterium naturally carried by some women. If passed from a mother to...

09:00
Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced that it has added another product to its growing generic portfolio, supporting its commitment to expanding and diversifying its product offerings. The Company has launched four new...

09:00
Parkinson's disease and essential tremor patients can now benefit from upgraded functionality with Abbott's Infinitytm DBS system. Abbott  today announced U.S. Food and Drug Administration (FDA) approval for an over-the-air software upgrade for all...

08:05
Sensus Healthcare, Inc. , a medical device company specializing in the non-invasive treatment of non-melanoma skin cancers (NMSC) and keloids with Image-Guided Superficial Radiation Therapy (IGSRT), today announced that the Company has received...


1 août 2018

09:03
Wills Eye Hospital has been given Food and Drug Administration (FDA) approval to begin an early feasibility study (EFS) to implant the RETINA IMPLANT Alpha AMS sub-retinal device in patients blind due to Retinitis Pigmentosa (RP). The Alpha AMS is...

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...

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