Le Lézard

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

15 février 2017

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,...

08:30
BeyondSpring Pharmaceuticals, a global clinical stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's...

06:00
The FDA's Center for Devices & Radiological health granted de novo clearance for Prescient Surgical's CleanCision Wound Retraction and Protection System for surgical wound edge protection, retraction, and continuous cleansing with a sterile irrigant...


23 janvier 2017

14:49
Owlet Baby Care has submitted a 510(k) to the U.S. Food and Drug Administration (FDA), seeking clearance for a medical version of the Owlet Smart Sock. The application is now pending review. Owlet shared its third-party accuracy validation testing to...

08:35
7D Surgical announced today that it has received both 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a medical device license from Health Canada enabling the North American commercial launch of its innovative Machine-vision...

08:30
Building on the success of the ECHELON FLEXtm 60mm Powered Plus Stapler with Gripping Surface Technology (GST), Ethicon*, a leading global provider of medical devices, today announced that the ECHELON FLEXtm GST System1 (45mm) has received 510(k)...

07:00
Camber Spine Technologies, today announced that it has received 510(k) clearance for their Siconustm SI Joint Fixation System. Siconustm becomes the second product in the Camber Spine Technologies portfolio to treat sacroiliac disease, as a...

06:59
BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced its PleurXtm catheter system received U.S. Food and Drug Administration (FDA) 510(k) clearance for the use in specific non-malignant  recurrent pleural...


20 janvier 2017

11:15
OssDsign AB, a Swedish designer, manufacturer and distributor of next generation implants for cranial and facial reconstruction, today announced that it has received 510(k) clearance by the US FDA for marketing and sale of OSSDSIGN® Cranial PSI in...

09:00
Bone Index Ltd., one of Europe's top new manufacturers of medical devices, has received 510(k) clearance from the Food and Drug Administration (FDA) for the second generation Bindex® point-of-care device model to help in osteoporosis diagnosis....


19 janvier 2017

16:05
The U.S. Food and Drug Administration today approved Trulance (plecanatide) for the treatment of Chronic Idiopathic Constipation (CIC) in adult patients. "No one medication works for all patients suffering from chronic...

12:15
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it has received the 510(k) clearance for its Elecsys Troponin T Gen 5 STAT (TnT Gen 5 STAT) blood test for patients with a suspected heart attack. With this clearance, Roche is the first IVD company...

07:59
Allergan plc, , a leading global pharmaceutical company, announced today the approval of RHOFADEtm cream by the U.S. Food and Drug Administration (FDA) for the topical treatment of persistent facial erythema (redness) associated with rosacea in...

07:05
The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.1 Accelerated...

07:00
AbbVie , a global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) approved IMBRUVICA® (ibrutinib) for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who require systemic...