Le Lézard

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

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14 mai 2018

07:00
CurveBeam announced it has received FDA 510(k) clearance for its LineUP Multi-extremity weight bearing CT system. The compact system enables radiologists and orthopedic specialists to visualize three-dimensional bone...

01:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today FDA approval of an additional claim for the cobas® Zika test for use on the cobas® 6800/8800 Systems.  The newly approved claim allows for the streamlined screening of multiple individual blood or...


11 mai 2018

18:35
Novartis today announced that the US Food and Drug Administration (FDA) has approved Gilenya® (fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis, making it the first...

16:28
The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients. ...

16:01
Perrigo Company plc today announced that it expects to receive a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its Abbreviated New Drug Application (ANDA) for its generic version of ProAir® (albuterol sulfate)...


9 mai 2018

16:05
AcelRx Pharmaceuticals, Inc. , (AcelRx), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today reported its first quarter 2018 financial results. "The first quarter of this year was...


8 mai 2018

09:02
Acutus Medical®, a global heart rhythm technology company, today announced that the AcQMap® High Resolution Imaging and Mapping System has been utilized for the first time in U.S. patients. The company also revealed initiation of a new clinical study...

08:00
Debiopharm International SA (Debiopharm - www.debiopharm.com), part of Debiopharm Grouptm, a Swiss-based global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to...

08:00
Debiopharm International SA (Debiopharm - www.debiopharm.com), membre de Debiopharm Grouptm, une société pharmaceutique basée en Suisse, a annoncé aujourd'hui que la Food and Drug Administration des États-Unis (FDA) a accordé la désignation...

07:59
AstraZeneca today announced Health Canada's approval for Lynparza® (olaparib) tablets, as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed (PSR), high-grade epithelial ovarian, fallopian tube or primary...

07:59
AstraZeneca a annoncé aujourd'hui que Santé Canada avait approuvé les comprimés Lynparza® (olaparib) en monothérapie pour le traitement d'entretien des patientes adultes atteintes d'un cancer épithélial séreux de haut grade de l'ovaire, des trompes...

03:00
Debiopharm International SA (Debiopharm - www.debiopharm.com), membre de Debiopharm Grouptm, une société pharmaceutique basée en Suisse, a annoncé aujourd'hui que la Food and Drug Administration des États-Unis (FDA) a accordé la désignation...

03:00
Debiopharm International SA (Debiopharm - www.debiopharm.com), part of Debiopharm Grouptm, a Swiss-based global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to...


7 mai 2018

22:39
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved DARZALEX® (daratumumab) in combination with VELCADE® (bortezomib)*, a proteasome inhibitor (PI); melphalan, an...

21:00
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the use of mirabegron in combination...

13:56
Today, the U.S. Food and Drug Administration permitted marketing of Hemospray, a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract. "The device provides an additional,...

10:00
CardioFocus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of paroxysmal atrial fibrillation (PAF)*....

07:00
Date de lancement aux États-Unis : deuxième trimestre 2018   En Europe, PLENVU® est distribué par Norgine   Norgine B.V. a annoncé aujourd'hui que l'Agence américaine des produits alimentaires et médicamenteux (US FDA) a approuvé PLENVU®...

07:00
Salix Pharmaceuticals, Ltd. ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases and a wholly owned subsidiary of Valeant Pharmaceuticals International,...

07:00
US launch date: second half of 2018  In Europe, PLENVU® is available through Norgine  Norgine B.V. today announced that the US Food and Drug Administration (FDA) has approved PLENVU® (NER1006), an osmotic laxative indicated for cleansing of the...

07:00
Kindred Biosciences, Inc. , a biopharmaceutical company focused on saving and improving the lives of pets, today announced that the U.S. Food and Drug Administration's Center for Veterinary Medicine approved Mirataz (mirtazapine transdermal ointment)...


6 mai 2018

20:00
STA Pharmaceutical Co., Ltd., (WuXi STA), a subsidiary of WuXi AppTec, announces that its active pharmaceutical ingredient (API) R&D and manufacturing facility located in Changzhou, China has secured Pre-Approval Inspection (PAI) for two APIs from...


4 mai 2018

12:42
The U.S. Food and Drug Administration approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body...

08:00
PaxVax, a leading independent specialty vaccine company, announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its vaccine for the prevention of disease caused by the chikungunya virus....


3 mai 2018

14:58
Histogen, Inc., a regenerative medicine company focused on stimulating the body's stem cells to regenerate tissues and restore youthful function, has received approval of its Investigational New Drug (IND) application from the US Food and Drug...

09:00
Abbott  today announced U.S. Food and Drug Administration (FDA) clearance of the Advisortm HD Grid Mapping Catheter, Sensor Enabledtm. Advisor HD Grid employs a new design that allows physicians to see things differently, capturing and analyzing data...

08:00
Forty Seven, Inc., a clinical-stage company focused on developing checkpoint therapies to activate macrophages in the fight against cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted two Fast Track designations to...


2 mai 2018

17:36
Takeda Pharmaceutical Company Limited (Takeda; TSE: 4502) and H. Lundbeck A/S (Lundbeck; LUN.CO, LUN DC, HLUYY) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application for TRINTELLIX® (vortioxetine)....

08:26
Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International , today announced that the U.S. Food and Drug Administration (FDA) has approved the Bausch + Lomb ULTRA® family of contact lenses...

07:30
Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced that the U.S. Food and Drug Administration (FDA) has granted pre-market supplemental approval (PMA) for its coflex®...

07:00
REGENXBIO Inc. , a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that the U.S. Food and Drug Administration...


1 mai 2018

16:41
Novartis today announced the US Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for its second indication ? the treatment of adult patients with relapsed or refractory (r/r) large B-cell...

13:28
Actelion Pharmaceuticals Ltd, qui fait partie des Sociétés pharmaceutiques Janssen de Johnson & Johnson, a annoncé...


30 avril 2018

16:29
Novartis announced today that the US Food and Drug Administration (FDA) has approved Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutation, as detected...

10:37
Meditech Spine, LLC, announced today it has received additional 510(k) clearance for its CURE Lumbar Plating (LP) System from the US Food and Drug Administration (FDA). The CURE LP iView and Cure LP QMax System clearance compliments Meditech's recent...

09:00
Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced the submission of a supplemental New Drug Application...

09:00
Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted...

08:00
Body Vision Medical, a medical device company specializing in augmented real-time imaging, artificial intelligence and intra-body navigation, announced today that it has received clearance from the U.S. Food and Drug Administration to market their...


26 avril 2018

11:07
Mobius Imaging, LLC, announced today that it has received 510(k) clearance for its Airo® Mobile CT Imaging System for pediatric applications. The Airo Mobile CT Imaging System previously received 510(k) clearance in 2013 for non-pediatric imaging and...

10:00
Dynamic MUSICA processes fluoroscopic images with the same high-quality/low-dose features, providing greater diagnostic confidence The DR 800 includes a range of features and tools that minimize exam preparation time, procedure time and the wait for...


25 avril 2018

08:30
Theravance Biopharma, Inc. ("Theravance Biopharma") today highlighted that the US Food and Drug Administration (FDA) has approved an expanded indication for Trelegy Ellipta. This expanded approval in the US allows Trelegy Ellipta to be used as a...

08:05
Hologic, Inc. announced today that the United States Food and Drug Administration (FDA) has granted premarket approval (PMA) for the ThinPrep® Integrated Imager, which will make automated imaging of Pap tests more broadly available to laboratories...

07:30
Global pharmaceutical company Mylan N.V. today announced the U.S. launch of Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg, a generic version of Bayer's Yaz® Tablets. Mylan Pharmaceuticals received final approval from the U.S. Food and...

05:00
The US Food and Drug Administration have accepted an application for a clinical development study on Dronabinol Inhalation using Senzer's unique breath-actuated inhaler, progressing the Company's US partner, INSYS Therapeutics, on its path for...


24 avril 2018

17:19
The PKD Foundation is excited to announce that on April 24 the U.S. Food and Drug Administration (FDA) granted approval of JYNARQUEtm (pronounced jin-AR-kew and also known as tolvaptan) to be the first treatment in the United States for adult...

16:02
Kindred Biosciences, Inc. , a biopharmaceutical company focused on saving and improving the lives of pets, today announced that it has received a response from the Food and Drug Administration (FDA) for the Chemistry, Manufacturing, and Controls...

10:10
Lin BioScience, a drug development company targeting unmet clinical needs in oncology, ophthalmology and metabolic diseases, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to LBS-007 for acute...

08:00
Quotient Limited ("Quotient") , an established, commercial-stage diagnostics company, today announced the recent FDA approval for U.S. commercialization of seven new blood bank reagents including two market firsts.      (Logo:...

03:00
Quotient Limited ("Quotient") , an established, commercial-stage diagnostics company, today announced the recent FDA approval for U.S. commercialization of seven new blood bank reagents including two market firsts.      (Logo:...


23 avril 2018

20:11
Eli Lilly and Company and Incyte Corporation announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of...

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