Le Lézard

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

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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...

08:33
Perrigo Company plc today announced it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for the generic version of Picato® Gel (ingenol mebutate) 0.05%. The submission date of Perrigo's Abbreviated New Drug...


1 novembre 2017

09:44
Intellijoint Surgical®, a medical technology company, is pleased to announce that it has received FDA Clearance for revision Total Hip Arthroplasty (THA) with its intellijoint HIP® System. A 3D Mini-Optical Navigation System, intellijoint HIP®...

08:45
IntraFuse, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for its FlexThreadtm Fibula Pin System. The IntraFuse...

08:30
The U.S Food and Drug Administration is taking advantage of latest policy guidance spelled out in past years to speed drug approvals. Thirty-four new drug products and advanced medicines, treating everything from cancer to rare genetic diseases, have...


31 octobre 2017

16:05
Luminex Corporation today announced that it has received FDA clearance for the ARIES® Group A Strep Assay, a moderate complexity, sample to answer test for the direct detection of Streptococcus pyogenes from throat swab specimens using the ARIES®...

15:54
Avella announced that it has been selected by AstraZeneca to distribute CALQUENCE® (acalabrutinib), a Bruton tyrosine kinase (BTK) inhibitor indicated for patients with mantle cell lymphoma (MCL) who have received at least one prior...

14:54
AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to CALQUENCE® (acalabrutinib). CALQUENCE is a kinase...

12:08
The U.S. Food and Drug Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. "Mantle cell...

11:03
Award-winning medical technology company EYE TECH CARE has received approval from the China Food and Drug Administration (CFDA) to begin marketing its EyeOP1® glaucoma treatment product in China. The first non-invasive medical device approved for...

09:00
Abbott has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its Alinitytm ci-series instruments for clinical chemistry and immunoassay diagnostics. These innovative testing solutions were designed to help the lab more effectively...

09:00
BRH Medical, a medical device company developing and marketing innovative products for increasing blood flow and pain reduction, announced today that it has received 510 (k) clearance from the US Food and Drug Administration ("FDA") for its...

08:45
The FDA has approved 34 drugs to date in 2017 after approving 22 novel drugs last year. Many biotech and pharma companies have dealt with the drug development process being lengthy and time-consuming along with requiring the utilization of a lot of...


30 octobre 2017

09:15
Equashield (http://www.equashield.com), a leading provider of Closed System Transfer Devices (CSTDs) for hazardous drugs, announced today that its Spanish distributor, Palex Medical, will expand distribution of Equashield's CSTDs through its...

08:00
Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration (FDA) approved the 10 mg once-daily dose of XARELTO® (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing at...

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