Le Lézard

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

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5 décembre 2017

08:00
Genea Biomedx today announced the FDA 510k clearance for its benchtop incubator Geritm. Geritm, an innovative continuous embryo monitoring benchtop incubator designed to offer individualised and undisturbed incubation for embryos during IVF...

08:00
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the FDA 510(k) clearance of the benchtop embryo incubator GeriTM. This innovative technology, designed to improve processes in...


4 décembre 2017

15:03
Sanofi Genzyme, une division de Sanofi-Aventis Canada Inc. et l'unité commerciale mondiale des soins spécialisés de Sanofi, ont annoncé aujourd'hui l'approbation de Santé Canada de DupixentMC (dupilumab), qui est indiqué pour le traitement des...

15:02
Sanofi Genzyme, a Division of sanofi-aventis Canada Inc. and the specialty care global business unit of Sanofi, announced today the Health Canada approval for Dupixenttm (dupilumab) for the treatment of adult patients with moderate-to-severe atopic...

11:45
Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration granted final approval for its Abbreviated New Drug Application for Megestrol Acetate Oral Suspension, a generic version of Megace®ES by Strativa...

09:15
EMD Serono, Canada, la société biopharmaceutique affiliée de Merck KGaA, Darmstadt, Allemagne, aux États?Unis et au Canada, a annoncé aujourd'hui l'approbation par Santé Canada de MAVENCLADMC (comprimés de cladribine) en monothérapie pour le...

09:15
EMD Serono, Canada, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, announced today that Health Canada has approved MAVENCLADtm (cladribine tablets) as monotherapy for the treatment of adult patients with...

07:30
Mylan N.V. and its partner, Aspen (JSE: APN), today announced the U.S. launch of Myleran (busulfan) Injection, 60 mg/10 mL (6 mg/mL) Single-dose Vial, a generic version of Otsuka Pharmaceutical's Busulfex® Injection. Aspen received final approval...

07:03
Moffitt Cancer Center announced that last week it treated the first patient commercially in the United States with the recently Food and Drug Administration-approved Yescartatm, a Chimeric Antigen Receptor T cell, or CAR-T, therapy for patients with...


1 décembre 2017

17:01
Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active psoriatic arthritis (PsA).1 Taltz was first approved by the FDA in...

16:00
Amgen today announced that following priority review of its supplemental Biologics License Application, the U.S. Food and Drug Administration (FDA) approved Repatha® (evolocumab) as the first PCSK9 inhibitor to prevent heart attacks, strokes and...

11:31
Mylan N.V. and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's Ogivritm (trastuzumab-dkst), a biosimilar to Herceptin® (trastuzumab), co-developed with Biocon. Ogivri...

10:50
Mylan N.V. , a global pharmaceutical company, today announced it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Heparin Sodium Injection USP, 1,000 USP/mL, 5,000...

10:40
The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma)...

06:53
Lannett Company, Inc. today announced that the 505(b)(2) New Drug Application (NDA) for Cocaine Hydrochloride (HCl) Topical Solution, 4% and 10%, with a proposed trade name of Numbrinotm, has been accepted for filing with standard review by the U.S....


30 novembre 2017

20:59
Indivior PLC (LON: INDV) today announced that the U.S. Food and Drug Administration (FDA) has approved SUBLOCADETM (buprenorphine extended- release) injection for subcutaneous use (CIII), the first and only once-monthly injectable buprenorphine...

19:26
With the approval today of a monthly formulation of the drug buprenorphine for the treatment of opioid use disorder, patients have access to a new and longer-acting option for the treatment of opioid addiction. Millions of Americans are suffering...

19:17
The U.S. Food and Drug Administration today approved Sublocade, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a...

16:45
The U.S. Food and Drug Administration today approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing (NGS)-based in vitro diagnostic (IVD) test that can detect genetic mutations in 324 genes and two...

10:09
Ricoh today announced that the RICOH MEG Measurement System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). RICOH MEG, Ricoh's magnetoencephalography system, is a noninvasive way to detect...

08:30
Mitsubishi Tanabe Pharma America, Inc. (MTPA) announced today that the U.S. Department of Veterans Affairs (VA) has added RADICAVA® (edaravone) to its National Formulary (VANF), with a national prior authorization process in place, making it possible...

08:30
Cordis, a Cardinal Health company, and Medinol today announced United States Food and Drug Administration (FDA) approval of the EluNIRtm drug-eluting stent (DES) for the treatment of patients with narrowing or blockages to their coronary arteries....

07:00
ArmaGen, Inc., a privately held biotechnology company focused on developing groundbreaking therapies to treat severe neurological disorders, today reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to...

03:01
AliveCor, the leader in FDA-cleared personal electrocardiogram (EKG) technology, today announced FDA clearance of KardiaBand in the U.S., allowing Apple Watch users to discreetly capture their EKG anytime, anywhere in order to quickly detect normal...


29 novembre 2017

08:45
The Natural Algae Astaxanthin Association (NAXA) has filed a citizen petition with the U.S. Food and Drug Administration (FDA) asking the agency to make the determination that Cardax's ZanthoSyn product is misbranded and adulterated. The petition...

08:00
The U.S. Food and Drug Administration (FDA) has granted Ferring Pharmaceuticals Inc. approval to market CLENPIQtm (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for cleansing of the colon in adults undergoing a...

04:00
INSIGHTEC, the leader in MR-guided Focused Ultrasound (MRgFUS) therapy, announced today that the Taiwanese Food and Drug Administration (TFDA) has approved its Exablate Neuro system for the treatment of essential tremor in patients who do not respond...


28 novembre 2017

08:30
NeuroproteXeon, Inc. announced the publication of a second finding from a randomized, controlled Phase II trial of inhaled xenon and oxygen, combined with hypothermia, for out-of-hospital cardiac arrest patients.  The study, which appeared in today's...


27 novembre 2017

11:36
Cochlear Limited (ASX: COH), the world leader in implantable hearing solutions, has received U.S. Food and Drug Administration approval for the first remote feature to allow follow-up programming sessions for the Nucleus® Cochlear Implant System...

10:00
RSNA 2017 -- IMRIS and Hill-Rom announced that Hill-Rom's Trumpf Medical has completed device listing and registration with the U.S. Food and Drug Administration (FDA) for a new multi-functional operating room table specifically designed for the...

09:52
Earlier this year, in an unprecedented, fast-tracked review, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) as the first immunotherapy treatment for advanced pancreatic cancer patients whose tumors are mismatch repair...

09:00
INSIGHTEC, the world leader of MR-guided Focused Ultrasound announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a study to evaluate the safety and feasibility of the Exablate Neuro for disrupting...

04:00
- More patients can benefit from non-invasive assessment of the liver through expanded compatibility with MRI systems - LiverMultiScantm comprehensive analysis allows the clinician to visualize heterogeneous liver tissue and assist in clinical...


26 novembre 2017

11:00
MIM Software Inc., a leading global provider of medical imaging software, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for post-treatment dosimetry of Yttrium-90 (Y90) microspheres. Yttrium-90...

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...

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