Le Lézard

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

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19 janvier 2018

06:03
Grünenthal announced today that Adhesys Medical GmbH, a wholly-owned subsidiary of the Grünenthal Group, has received CE-Certification for MAR-CUTIS (Flix®). Flix® is a topical skin adhesive for surgical use and the first product from Grünenthal's...


18 janvier 2018

17:00
Medizone International, Inc. or Medizone, manufacturer of the AsepticSure® system, today announced that as a result of its meeting with representatives of the U.S. Food and Drug Administration ("FDA") on January 18, 2018, it has reached decisions...

16:05
QIAGEN N.V. today announced that the U.S. Food and Drug Administration (FDA) has approved a PMA supplement extending the indications for use of QIAGEN's therascreen® EGFR RGQ PCR Kit as a companion diagnostic to guide the use of Boehringer...

08:30
Aquestive Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application for clobazam Oral Soluble Film (clobazam OSF) for adjunctive treatment of seizures associated...

03:00
Biohaven Pharmaceutical Holding Company Ltd. (Biohaven or the "Company") and its wholly owned subsidiary, Biohaven Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it may proceed...


17 janvier 2018

16:15
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for...

09:00
Lyric Pharmaceuticals, Inc (Lyric), a biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of ulimorelin (LP101) for the treatment of enteral...

08:00
International Biophysics Corporation, a global medical device manufacturer based in Austin, Texas, announced they have received FDA 510k clearance for their FloPump 32 centrifugal disposable heart pump. The FloPump 32 is one of the smallest...

06:00
Outpost Medicine, a biopharmaceutical company focused on the development of new treatments of urologic and gastrointestinal disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted two Investigational New Drug (IND)...


16 janvier 2018

08:30
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced findings from the U.S. Food and Drug Administration's (FDA) Mini-Sentinel assessment, confirming the positive safety and efficacy profile of XARELTO® (rivaroxaban) established...

08:00
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) for the first-line treatment of patients with metastatic non-small cell lung cancer...

01:20
Sandoz, a Novartis division and the global leader in biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed...


15 janvier 2018

02:04
PLENVU® est la première préparation intestinale d'un litre à base de PEG Il a été prouvé que PLENVU® était supérieur à MOVIPREP® pour provoquer un nettoyage de haute qualité du côlon ascendant - une région importante pour la détection des adénomes...

02:00
PLENVU® is the first 1-litre PEG bowel preparation PLENVU® is superior to MOVIPREP® in providing high-quality cleansing in the colon ascendens - an important area for adenoma detection Norgine B.V. today announced marketing authorisation for...


12 janvier 2018

09:39
The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited...

08:00
GSK [LSE/NYSE: GSK] announced today it has received approval from the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research expanding the indication for FLUARIX® QUADRIVALENT (Influenza Vaccine) to include use in...

07:00
Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. ("Valeant") , today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application for IDP-121 (tretinoin 0.05%) lotion (ALTRENOtm1)...


11 janvier 2018

15:31
Aujourd'hui, Novo Nordisk a annoncé que Santé Canada a approuvé Ozempic® (semaglutide en injection) en tant que complément au régime alimentaire et à l'exercice physique pour améliorer la maîtrise glycémique chez les adultes atteints de diabète sucré...

07:00
Norgine B.V. today announced the launch of LYMPHOSEEK® (Tc 99m tilmanocept) in Finland and Sweden. LYMPHOSEEK® is a radiopharmaceutical used for diagnostic purposes by nuclear medicine specialists and surgeons. It is specifically designed for a...

07:00
Norgine B.V. a annoncé aujourd'hui le lancement de LYMPHOSEEK® (Tm 99m tilmanocept) en Finlande et en Suède. LYMPHOSEEK® est un produit radiopharmaceutique utilisé à des fins diagnostiques par les chirurgiens et les spécialistes de la médecine...

06:30
Boston Scientific Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved the Spectra WaveWritertm Spinal Cord Stimulator (SCS) System. It is the first and only system approved by the FDA to simultaneously provide...


10 janvier 2018

08:00
AstraZeneca today announced that BYDUREON® BCisetm (exenatide extended-release) injectable suspension 2mg is now available in pharmacies across the United States. BYDUREON BCise was recently approved by the U.S. Food and Drug Administration for...

04:08
La FDA a accordé une approbation d'exemption pour dispositif expérimental (IDE - Investigational Device Exemption approval) pour mener une étude clinique examinant l'utilisation du système de ballon ProSpacetm dans le but d'éviter la toxicité rectale...

04:07
FDA has granted investigational Device Exemption approval (IDE) to conduct a pivotal clinical study examining the use of the ProSpace[TM] Balloon System to prevent rectal toxicity following prostate cancer radiotherapy BioProtect, the...


9 janvier 2018

09:00
BioProtect, the technology leader in biodegradable balloon spacers protecting normal tissue during radiation therapy, announced the launch of its clinical trial following Investigational Device Exemption (IDE) approval granted by the FDA in November...

08:00
Novo Nordisk announced today that Health Canada has approved Ozempic® (semaglutide injection) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, when metformin is not tolerated or contraindicated.1...

08:00
Novo Nordisk announced today that Health Canada has approved Ozempic® (semaglutide injection) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, when metformin is not tolerated or contraindicated.1...

07:00
Cepheid announced today 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 test. The test can be performed in near-patient settings,...

03:00
Xcision Medical Systems, LLC has announced that the GammaPod Stereotactic Radiotherapy System, the world's first noninvasive external beam system optimized for partial breast treatments, has received 510(k) clearance from the US Food and Drug...


8 janvier 2018

09:00
Clearbridge BioMedics today announced that it has successfully registered its target cell enrichment device, the ClearCell® FX1 system, with the U.S. Food and Drug Administration (FDA) as a Class I Medical Device, for in vitro diagnostic use. This...

08:10
Varian today announced its Halcyontm system has received Taiwan FDA approval, which allows the company to market this new cancer treatment system in Taiwan.  This approval further expands the global availability of Halcyon and high-quality,...

08:00
Nevro Corp. , a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that it has received FDA approval for its next-generation Senza II Spinal Cord Stimulation (SCS)...

08:00
AbbVie , a global research and development-based biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational, once-daily oral JAK1-selective inhibitor...

08:00
STS Medical Ltd. ("S.T.Stent"), a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T; OTCQX: TRNLY), announced today that it received regulatory clearance from the United States Food and Drug Administration (FDA) for its...


5 janvier 2018

09:00
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for XGEVA® (denosumab) to expand the currently approved indication for the prevention of skeletal-related...

09:00
Spruce Biosciences, a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders, today announced that the European Medicines Agency (EMA) has granted orphan drug designation for SPR001 for the treatment of...


4 janvier 2018

11:01
Cerebrotech Medical Systems, an innovative medical device company developing neurotechnology solutions, has received clearance from the Food and Drug Administration, or FDA, for the Cerebrotech Visor, previously known as the CMS-5000tm Intracranial...

10:45
Sight Sciences, Inc., a venture-backed, commercial stage ophthalmic device company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its OMNItm Surgical System, a surgical tool dually indicated for the delivery of...

07:15
Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Promacta® (eltrombopag) for use in combination with standard immunosuppressive therapy for the treatment of patients with severe...


3 janvier 2018

16:30
Zimmer Biomet Holdings, Inc. , a global leader in musculoskeletal healthcare, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the Sidus® Stem-Free Shoulder system as a total shoulder arthroplasty solution for...

10:03
Cantex Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing proprietary pharmaceuticals that improve the treatment of cancers and other life-threatening disorders, today announced that the U.S. Food and Drug...

10:00
The Population Council today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its one-year Nestorone® / ethinyl estradiol vaginal ring for pregnancy prevention. If approved, the contraceptive vaginal ring would be...

09:00
Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is proud to announce the clearance of QUANTA Flash® Calprotectin by the US Food and Drug Administration (FDA). QUANTA Flash...

09:00
Abbott  today announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for the Quadra Assura MPtm Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Fortify Assuratm Implantable Cardioverter...

08:09
Perrigo Company plc today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Prolensa® (bromfenac ophthalmic solution) 0.07%. Perrigo previously settled litigation with Bausch & Lomb...

08:00
Janssen Pharmaceuticals, Inc., today announced INVEGA SUSTENNA® (paliperidone palmitate), a once-monthly schizophrenia treatment, is the first and only antipsychotic to have the U.S. Food and Drug Administration (FDA) approve the inclusion of...

07:15
Novartis today announced Kisqali® (ribociclib) received US Food and Drug Administration (FDA) Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal...


29 décembre 2017

10:47
Global pharmaceutical leader Mylan N.V. today announced the U.S. launch of Estradiol Vaginal Cream USP, 0.01%, the first generic version of Allergan's Estrace® Cream. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for...


28 décembre 2017

13:57
Today, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.  "Diabetes is the leading cause of lower limb...


23 décembre 2017

04:00
Abdi Ibrahim Remede Pharma (AIRP) is Biocon's partner in Algeria for the registration, marketing and pharmacovigilance monitoring of multiple Biotech Products. In 2016, AIRP launched the first Biosimilar of Trastuzumab (CANMAb®) in Algeria...

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