Le Lézard

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

22 février 2017

08:00
LifeBond, a leader in the development of bio-surgical medical devices for tissue repair, announced today that 20 leading medical centers in the United States and Western Europe are now recruiting for the company's international pivotal study of its...

07:58
Kalorama Information presents five news stories related to in vitro diagnostics that represent significant developments.  Among the top news stories in IVD this month, Roche moves into the hematology market with a European product launch, new options...

06:59
Effective Feb. 13, 2017, the Food and Drug Administration (FDA) has reclassified antigen based rapid influenza virus antigen detection systems (RIDTs) intended to detect influenza virus directly from clinical specimens from Class I devices into Class...

06:54
Lannett Company, Inc. today announced that it was notified by U.S. Food and Drug Administration (FDA) late yesterday afternoon that FDA suspended indefinitely the deadline for the Company to submit materials in support of its request for a hearing...


20 février 2017

07:30
Intensix, developer of a real-time predictive analytics platform for early detection of patient deterioration in the ICU and high acuity departments of hospitals, announced today the positive results of a clinical study of the effectiveness of the...


17 février 2017

08:42
Perrigo Company plc today announced it has received final approval from the U.S. Food and Drug Administration for hydrocodone bitartrate and homatropine methylbromide oral solution (syrup), 5 mg/1.5 mg per 5 mL....


16 février 2017

08:08
Mylan N.V. and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta®  (pegfilgrastim),...

08:00
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved SPIRIVA RESPIMAT for the long-term, once-daily maintenance treatment of asthma in people age 6 and older. SPIRIVA RESPIMAT is not a...

07:00
Valeant Pharmaceuticals International, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for SILIQtm (brodalumab) injection, for subcutaneous use, a monoclonal antibody that...


15 février 2017

17:56
The U.S. Food and Drug Administration today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection. Siliq is intended for patients who are candidates for systemic therapy...

10:42
PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System from BIOTRONIK gained FDA approval utilizing results from the BIOHELIX-I clinical study. This stent, which has already been used to treat more than 650,000 patients worldwide, is now...

08:00
IBSA announced today that the US Food and Drug Administration (FDA) has approved Tirosint-SOL (levothyroxine sodium oral solution), a liquid form of levothyroxine for the following two conditions: hypothyroidism and TSH suppression in the management...

07:00
Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Xpress Flu and Xpert Xpress Flu/RSV. Both tests deliver reference-quality molecular results in as little as twenty minutes. The...

03:00
Clinical Studies have Demonstrated that Tirosint-sol may Overcome Some of the Limitations of Levothyroxine Tablets   IBSA announced today that the US Food and Drug Administration (FDA) has approved Tirosint-SOL (levothyroxine sodium oral solution),...

02:00
Des études cliniques ont démontré que Tirosint-SOL peut vaincre certaines des limites inhérentes aux comprimés de lévothyroxine    IBSA a annoncé aujourd'hui que le Secrétariat américain aux produits alimentaires et pharmaceutiques (FDA, Food and...


13 février 2017

09:08
Dr. Robert I. Fox and Professor Simon Bowman are world-renowned rheumatologists and experts in Sjogren's syndrome    XTL Biopharmaceuticals Ltd., is a clinical-stage biotech company focused on the development of pharmaceutical products for the...

09:02
The Institute for Endocrinology and Diabetes at Schneider Children's Medical Center in Petah Tikva, Israel, along with the International Diabetes Center (IDC) received a grant of $6.94 million to study the next generation of hybrid closed loop...


9 février 2017

17:55
The Muscular Dystrophy Association today welcomed news of the U.S. Food and Drug Administration's decision to grant approval for deflazacort (brand name Emflaza), under development by Marathon Pharmaceuticals, to treat the most common childhood form...

13:54
The U.S. Food and Drug Administration today approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle...

08:00
Access Scientific, LLC, announced today the FDA clearance of its new 3 French, 6cm POWERWANDtm-- the first true Extended-Dwell Intravenous Catheter (EDC). The IV catheter is uniquely designed for forearm and upper-arm (midline) placement to eliminate...


8 février 2017

06:45
The label for Eli Lilly and Company's once-weekly Trulicity® (dulaglutide) is now updated to include use in combination with basal insulin for adults with type 2 diabetes. The U.S. Food and Drug Administration (FDA) included the changes to the...


7 février 2017

18:13
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved Parsabivtm (etelcalcetide) for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Parsabiv is...

10:30
Bio Products Laboratory Limited (BPL), a leading manufacturer of plasma-derived protein therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved Gammaplex® 10% (immune globulin intravenous [human], 10% liquid) for the...

08:30
Bioness, Inc., the leading provider of cutting-edge, clinically supported rehabilitation therapies, today announced that it received clearance from the U.S. Food and Drug Administration (FDA) for the L300 Gotm System. The L300 Go builds upon the...

08:00
Emmaus announced today the allowance of patent application number 2014-542296, by the Japanese Patent Office for the use of its lead investigative product, pharmaceutical grade L-glutamine (PGLG), for the treatment of diabetes. A related patent...


6 février 2017

18:39
Inova Diagnostics, a worldwide leader in autoimmune diagnostic reagents and systems for the clinical laboratory, announced today that the United States Food and Drug Administration (FDA) has granted 510(k) clearance of NOVA Lite® DAPI ANCA (Ethanol)...

12:30
Baebies, a company focused on advancing newborn screening and pediatric testing, announced today it has received de novo clearance from the U.S. Food and Drug Administration (FDA) for SEEKER. SEEKER quantitatively measures the activity of lysosomal...

09:00
Kindred Biosciences, Inc. , a biopharmaceutical company focused on saving and improving the lives of pets, today announced it has received a technical section complete letter for effectiveness from the U.S. Food and Drug Administration's Center for...


3 février 2017

17:41
Intarcia Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for active review its New Drug Application (NDA) for ITCA 650, an investigational therapy for the treatment of type 2 diabetes (T2D). Intarcia...


2 février 2017

08:00
AbbVie , a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority review for its investigational, pan-genotypic regimen of...

08:00
Abbott  announced today that the U.S. Food and Drug Administration (FDA) has authorized its molecular test, the Abbott RealTime ZIKA test, to detect Zika virus in whole blood (when collected alongside a patient-matched serum or plasma sample) for...


1 février 2017

16:30
Zimmer Biomet Holdings, Inc. , a global leader in musculoskeletal healthcare, today announced that the U.S. Food and Drug Administration (FDA) approved an expanded 26-week efficacy claim for its single-injection viscosupplement Gel-One® Cross-linked...

09:15
Equashield, a leading provider of Closed System Transfer Devices (CSTDs) for the safe and simple handling of hazardous drugs, today announced the results of two comparative studies conducted at the University of North Carolina, confirming...

08:38
Patent Further Strengthens Company's IP position ahead of Planned New Drug Application to be Submitted to FDA Kitov Pharmaceuticals Holdings Ltd. , an innovative biopharmaceutical company, announced today that the U.S. Patent and Trademark Office...

08:00
Abbott today announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for both the Assurity MRItm pacemaker and the Tendriltm MRI pacing lead. Patients implanted with these low-voltage devices will...

08:00
Audentes Therapeutics, Inc. , a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases, today announced that the U.S. Food and Drug Administration (FDA)...

08:00
Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Xyzal® Allergy 24HR as an over-the-counter treatment for the relief of symptoms associated with seasonal and year-round allergies. Specifically, two formulations of...


31 janvier 2017

14:09
The U.S. Food and Drug Administration (FDA) in less than a 15-month period has granted a new and updated 510(k) clearance for two patented technologies made by NICO Corporation that are used in a new approach for brain surgery. Most recently, NICO...


30 janvier 2017

17:26
Endo International plc announced today that one of its operating companies, Par Pharmaceutical has received final approval from the U.S. Food and Drug Administration for its New Drug Application for ephedrine sulfate injection, a drug administered...

07:59
Allergan plc , a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) to update the label for AVYCAZ® (ceftazidime and avibactam) with...

07:00
Compugen Ltd. , a leading predictive drug discovery company, today announced that the Company will host a conference call on Wednesday, February 15, 2017 at 10:00 AM EST to review fourth quarter and yearend 2016 results. Compugen participants on the...


27 janvier 2017

07:00
OWC Pharmaceutical Research Corp. , ("OWC" or the "Company"), an Israeli-based developer of cannabinoid-based therapies targeting a variety of medical conditions and disorders, today announced that Ms. Miri Sani has accepted nomination to the...


26 janvier 2017

08:03
Gramercy Extremity Orthopedics (GEO) today announced it received the U.S. Food and Drug Administration's (FDA) 510(k) clearance for the GEOtm Bone Screw System, which can be used for bone fractures, osteotomies, arthrodesis, osteochondritis, and...

07:01
Ironwood Pharmaceuticals, Inc.  and Allergan plc  announced today that the U.S. Food and Drug Administration (FDA) has approved a 72 mcg dose of LINZESS® (linaclotide) for the treatment of chronic idiopathic constipation (CIC) in adult patients....


25 janvier 2017

08:34
Today, the U.S. Food and Drug Administration (FDA) approved NARCAN® Nasal Spray as a 2mg formulation for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. The 2mg...

08:00
AbbVie , a global biopharmaceutical company, announced the start of two Phase 2 clinical trial programs to evaluate ABBV-8E12, an investigational anti-tau antibody, in patients with early Alzheimer's disease and progressive supranuclear palsy (PSP)....


24 janvier 2017

17:15
Las Vegas ophthalmology practice, Center For Sight, announced today its introduction of the Raindrop Near Vision Inlay, the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery and...

16:10
In a major study released this weekend from the University Hospital Muenster, Germany1 (http://www.multivu.com/players/English/7899551-nephrocheck-test-acute-kidney-injury-outcomes/), Astute Medical's CE marked and FDA cleared NephroCheck® Test...

10:15
Mezzion has filed a suit for damages against Dr. Reddy's in New Jersey State court alleging that Dr. Reddy's committed fraud relating to Dr. Reddy's hiding significant deficiencies in its Food and Drug Administration (FDA) cGMP practices, and...

08:40
Perrigo Company plc today announced it has received U.S. Food and Drug Administration approval for its first-to-file Abbreviated New Drug Application referencing Taro Pharmaceuticals USA Inc.'s Topicort® Spray, 0.25% (desoximetasone topical spray,...