Le Lézard

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

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30 novembre 2017

10:09
Ricoh today announced that the RICOH MEG Measurement System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). RICOH MEG, Ricoh's magnetoencephalography system, is a noninvasive way to detect...

08:30
Mitsubishi Tanabe Pharma America, Inc. (MTPA) announced today that the U.S. Department of Veterans Affairs (VA) has added RADICAVA® (edaravone) to its National Formulary (VANF), with a national prior authorization process in place, making it possible...

08:30
Cordis, a Cardinal Health company, and Medinol today announced United States Food and Drug Administration (FDA) approval of the EluNIRtm drug-eluting stent (DES) for the treatment of patients with narrowing or blockages to their coronary arteries....

07:00
ArmaGen, Inc., a privately held biotechnology company focused on developing groundbreaking therapies to treat severe neurological disorders, today reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to...

03:01
AliveCor, the leader in FDA-cleared personal electrocardiogram (EKG) technology, today announced FDA clearance of KardiaBand in the U.S., allowing Apple Watch users to discreetly capture their EKG anytime, anywhere in order to quickly detect normal...


29 novembre 2017

08:45
The Natural Algae Astaxanthin Association (NAXA) has filed a citizen petition with the U.S. Food and Drug Administration (FDA) asking the agency to make the determination that Cardax's ZanthoSyn product is misbranded and adulterated. The petition...

08:00
The U.S. Food and Drug Administration (FDA) has granted Ferring Pharmaceuticals Inc. approval to market CLENPIQtm (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for cleansing of the colon in adults undergoing a...

04:00
INSIGHTEC, the leader in MR-guided Focused Ultrasound (MRgFUS) therapy, announced today that the Taiwanese Food and Drug Administration (TFDA) has approved its Exablate Neuro system for the treatment of essential tremor in patients who do not respond...


28 novembre 2017

08:30
NeuroproteXeon, Inc. announced the publication of a second finding from a randomized, controlled Phase II trial of inhaled xenon and oxygen, combined with hypothermia, for out-of-hospital cardiac arrest patients.  The study, which appeared in today's...


27 novembre 2017

11:36
Cochlear Limited (ASX: COH), the world leader in implantable hearing solutions, has received U.S. Food and Drug Administration approval for the first remote feature to allow follow-up programming sessions for the Nucleus® Cochlear Implant System...

10:00
RSNA 2017 -- IMRIS and Hill-Rom announced that Hill-Rom's Trumpf Medical has completed device listing and registration with the U.S. Food and Drug Administration (FDA) for a new multi-functional operating room table specifically designed for the...

09:52
Earlier this year, in an unprecedented, fast-tracked review, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) as the first immunotherapy treatment for advanced pancreatic cancer patients whose tumors are mismatch repair...

09:00
INSIGHTEC, the world leader of MR-guided Focused Ultrasound announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a study to evaluate the safety and feasibility of the Exablate Neuro for disrupting...

04:00
- More patients can benefit from non-invasive assessment of the liver through expanded compatibility with MRI systems - LiverMultiScantm comprehensive analysis allows the clinician to visualize heterogeneous liver tissue and assist in clinical...


26 novembre 2017

11:00
MIM Software Inc., a leading global provider of medical imaging software, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for post-treatment dosimetry of Yttrium-90 (Y90) microspheres. Yttrium-90...

08:07
Arterys Inc., the leader in intelligent cloud-based medical imaging software solutions, has announced the unveiling of their Arterys MICA platform at the 2017 Radiological Society of North America annual meeting (RSNA), November 26 - 30 in Chicago....


24 novembre 2017

08:05
Hologic, Inc. announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Quantratm 2.2 Breast Density Assessment Software, which enables clinicians to provide women with consistent breast...


22 novembre 2017

16:00
RxSight, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the RxSighttm Light Adjustable Lens and the Light Delivery Device (LDD) for patients with pre-existing astigmatism of ? 0.75 diopters undergoing cataract...

16:00
RxSight, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the RxSighttm Light Adjustable Lens and the Light Delivery Device (LDD) for patients with pre-existing astigmatism of ? 0.75 diopters undergoing cataract...

11:29
The U.S. Food and Drug Administration today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens' power after cataract surgery so that the...


21 novembre 2017

20:22
ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Juluca®, indicated as a complete...

19:45
ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Juluca®, indicated as a complete...

19:35
ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Juluca®, indicated as a complete...

18:06
Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced that the U.S. Food and Drug Administration (FDA) has approved JULUCA®, the first, complete, single-pill, two-drug regimen for the treatment of human immunodeficiency...

14:01
The U.S. Food and Drug Administration today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard...

11:37
Janssen Biotech, Inc. today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for DARZALEX® (daratumumab). This application seeks to expand the current indication, using...

08:05
US WorldMeds today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of the New Drug Application (NDA) for lofexidine, an investigational product to mitigate symptoms associated with opioid withdrawal...


20 novembre 2017

08:01
kaléo, a privately-held pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for AUVI-Q® (epinephrine injection, USP) 0.1 mg, the first and only epinephrine...

08:00
Volpara Solutions announced today that it has received regulatory clearances for its suite of quantitative breast imaging tools in Japan and Taiwan. In Japan, the full Volpara®Enterprisetm suite of products has received regulatory approval as a Class...


17 novembre 2017

14:46
The U.S. Food and Drug Administration today approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform. The remote programming feature is indicated for patients who have had...

08:39
Aujourdhui, Voluntis a annoncé qu'Insulia®, son logiciel compagnon pour les personnes souffrant de diabète de type 2, a reçu un agrément de la FDA et le marquage CE en vue d'intégrer le Basaglar et le Tresiba. Insulia est donc désormais disponible...


16 novembre 2017

16:02
The U.S. Food and Drug Administration today approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer (renal cell carcinoma) returning after a kidney has been removed (nephrectomy)....

14:21
Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that more than 1,000 people with amyotrophic lateral sclerosis (ALS) have been treated with RADICAVA® (edaravone) since it became available in the U.S. in August as the first FDA-approved...

08:45
Vermillion announced today the acceptance and publication of a novel paper, "Economic Impact of Increased Utilization of Multivariate Assay Testing to Guide the Treatment of Ovarian Cancer: Implications for Payers" in the journal American Health and...

08:00
SweeGen, Inc., a nature-based sweetener company, and Ingredion Incorporated, a leading global provider of ingredient solutions to diversified industries, jointly announced that the U.S. Food and Drug Administration (FDA) issued a GRAS (Generally...

08:00
Today, Voluntis announced that Insulia®, its digital companion for people with Type 2 diabetes, has received FDA clearance and the CE mark to integrate Basaglar and Tresiba. This now makes Insulia available for people using any brand of basal insulin...

07:15
TSO3 inc. (la « Société ») , une société innovatrice du domaine de la technologie de stérilisation des instruments médicaux en milieu hospitalier, a annoncé aujourd'hui qu'elle a répondu à la demande d'informations supplémentaires de la Food and Drug...

07:15
TSO3 Inc. , an innovator in sterilization technology for medical devices in healthcare settings, announced today that it has responded to the recent request for additional information (AI), from the U.S. Food and Drug Administration. This information...


15 novembre 2017

21:36
Ascentage Pharma, a global clinical-stage biopharmaceutical company dedicated to developing apoptosis-targeted therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for...

12:08
The U.S. Food and Drug Administration today approved Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. MPS VII is...

11:31
Today, the U.S. Food and Drug Administration granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal. "Given the scope of the epidemic of opioid...

10:36
Noden Pharma DAC, a global specialty pharmaceutical company that is focused on acquiring prescription medicines across a broad range of therapeutic areas, announced today the approval by the U.S. Food and Drug Administration of Tekturna®(aliskiren)...

08:00
Alcyone Lifesciences, Inc., announced that the U.S. Food and Drug Administration (FDA) cleared the Alivio Ventricular Catheter & Flusher System (Alivio System) for the treatment of hydrocephalus. This comes on the heels of Alcyone receiving the EU CE...


14 novembre 2017

19:02
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has approved FASENRAtm (benralizumab) for the add-on maintenance treatment of patients with severe asthma...

13:00
 -- The VENTANA MMR IHC Panel1 helps differentiate between sporadic colorectal cancer and probable Lynch syndrome, a hereditary form of colorectal cancer  -- The National Comprehensive Cancer Network recommends universal screening of all newly...

07:50
MedShape, Inc., the industry leader in orthopaedic devices using advanced functional materials, announced today that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the DynaNail® XL TTC Fusion System. The...

00:16
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital Health (Proteus) today announce that the United States Food and Drug Administration (FDA) has granted the first approval of a digital medicine system, ABILIFY MYCITE® (aripiprazole tablets...


13 novembre 2017

19:17
The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication...

08:15
New pen is easy-to-learn and easy-to-use, supporting the one in six couples affected by infertility in the U.S.[1]  Insights of patients, nurses and doctors helped to evolve the product  Merck, a leading science and technology company,...

07:35
Allergan plc today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for VRAYLARtm (cariprazine) for the maintenance treatment of adults with schizophrenia. VRAYLAR is also approved...

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