Le Lézard

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

15 novembre 2017

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...


26 octobre 2017

23:30
Veeda Clinical Research is glad to share the successful completion of 2 USFDA Inspections at 2 of its locations at Ahmedabad in Sep-2017. Both the Inspections were Routine Inspections by BIMO (BioResearch Monitoring Program - USFDA) covering Clinical...

09:00
Nitiloop, a medical device company dedicated to the development of Cardiovascular and peripheral microcatheters for complex lesions, received FDA clearance for its new Nova Crosstm Extreme and Nova Crosstm BTK. These dedicated microcatheters are...

08:07
Hologic, Inc. announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Panther Fusion® Paraflu assay, a multiplexed assay which runs on the new Panther Fusion® system. ...


25 octobre 2017

16:24
Agenus Inc. , an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted in...

07:00
Prometic Life Sciences Inc. (Prometic) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PBI-4050, a clinical candidate in development for idiopathic pulmonary fibrosis (IPF). The Fast Track...

07:00
Prometic Sciences de la Vie inc. (« Prometic » ou la « Société ») a annoncé aujourd'hui avoir obtenu une désignation accélérée de la Food and Drug Administration américaine (« FDA ») pour le PBI-4050, un médicament candidat en...

02:38
Swedish Orphan Biovitrum AB (publ) (Sobitm) today announces that the Saudi Food & Drug Authority (SFDA) in the Kingdom of Saudi Arabia has approved Alprolix® (eftrenonacog alfa), for the treatment of haemophilia B.  Alprolix is the first extended...


24 octobre 2017

09:20
Ortek Therapeutics, Inc. today announced that the Ortek ECDtm received 510(k) clearance from the U.S. Food and Drug Administration. The ECD is a patented lightweight tabletop device designed as an aid for dental professionals to diagnose and monitor...

09:08
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) 0.015%. The submission date of Perrigo's Abbreviated New Drug...

08:03
Acutus Medical® today announced that the U.S. Food and Drug Administration has cleared the AcQMap® High Resolution Imaging and Mapping System and the AcQMap® 3D Imaging and Mapping...

06:00
Denovo Biopharma, a leader in precision medicine, announced today that the US Food and Drug Administration (FDA) has granted DB102 the Investigational New Drug application (IND) clearance to proceed for a phase 3 trial to treat Diffuse Large B Cell...