Le Lézard

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

26 novembre 2017

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,...

08:00
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, received approval for a redesigned version of GONAL-f® RFF* Redi-ject® (follitropin alfa injection) pen injector from the U.S. Food and Drug...

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...


9 novembre 2017

09:00
Northwestern Medicine's urology department is excited to announce a minimally invasive treatment option for men with enlarged prostates. The UroLift® System is the first permanent implant to treat symptoms due to urinary outflow obstruction secondary...

08:30
Stryker Corporation announced today that the U.S. Food and Drug Administration has approved the Neuroform Atlastm Stent System for marketing under a humanitarian device exemption (HDE).  The device is to be utilized in conjunction with neurovascular...


8 novembre 2017

17:34
DT MedTech, LLC (DTM) today announced that the Hintermann Series H2tm Total Ankle Replacement System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The Hintermann Series H2tm is a...


7 novembre 2017

10:58
Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced it has obtained US Food and Drug Administration (FDA) approval for the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients...

06:00
Kent Imaging Inc., a leading innovator in multispectral oxygenation imaging, announced today that their handheld KD203 is a licensed medical device with Health Canada. Kent's device is also cleared with the U.S. Food and Drug Administration (FDA) and...


6 novembre 2017

11:40
The U.S. Food and Drug Administration today expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester Disease (ECD), a rare cancer of the blood. Zelboraf is indicated to treat patients...

08:00
Artemis Therapeutics, Inc. , ("Artemis" or the "Company"), a pharmaceutical company developing new therapies for the treatment of life-threatening infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) granted orphan...

08:00
VIMPAT® (lacosamide) CV oral formulations are approved as a monotherapy or adjunctive therapy in patients four years of age and older with partial-onset seizures (POS)1 Pediatric epilepsy is the most common, serious, treatable neurological disorder...

07:59
AstraZeneca Canada today announced that Health Canada has approved Imfinzi® (durvalumab) for the treatment of advanced bladder cancer in previously treated patients. Imfinzi, an immuno-oncology therapy that activates the body's own immune system to...

07:59
AstraZeneca Canada a annoncé aujourd'hui que Santé Canada avait approuvé l'emploi d'Imfinzi® (durvalumab) pour le traitement du cancer de la vessie avancé chez les patients ayant déjà été traités. Imfinzi, traitement d'immuno-oncologie qui active le...

07:00
Neovasc Inc. ("Neovasc" or the "Company") announced that it has received approval of the U.S. Food and Drug Administration ("FDA") to initiate the COSIRA-II IDE pivotal clinical trial.  The trial's purpose will be to demonstrate the safety and...


2 novembre 2017

22:10
La société de technologies médicales EYE TECH CARE, qui a reçu plusieurs prix d'innovation, a reçu l'autorisation de la part de l'Administration chinoise des produits alimentaires et pharmaceutiques (CFDA, pour China Food and Drug Administration)...

16:26
Valeant Pharmaceuticals International, Inc.'s wholly owned subsidiary, Bausch + Lomb, a leading global eye health company, and Nicox S.A. (Euronext Paris: FR0013018124, COX), an international ophthalmic company, today announced that the U.S. Food...

08:35
scPharmaceuticals, Inc., a pharmaceutical company focused on developing and commercializing products that have the potential to transform the way therapy is delivered, advance patient care and reduce healthcare costs, today announced that the...