Le Lézard

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

30 mars 2017

12:30
SRI International has received U.S. Food and Drug Administration (FDA) clearance for an Investigational New Drug (IND) application to evaluate a novel, oral formulation of zinc diethylene triamine pentaacetate (Zn-DTPA) as a treatment for radiation...

09:00
Upsher-Smith Laboratories, Inc. (Upsher-Smith) today announced that it has received U.S. Food and Drug Administration (FDA) final approval of two supplemental new drug applications (sNDAs) for Qudexy® XR (topiramate) Extended-Release Capsules for use...

07:00
AbbVie , a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the inclusion of moderate to severe fingernail psoriasis data in the HUMIRA® (adalimumab) prescribing information for patients with...

04:41
A New Non-stimulant Clinical Option for Children and Adolescents From 6 to 17 Years old With ADHD  Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that its partner in Japan, Shionogi & Co., Ltd, has received the approval of the Japanese Ministry...

02:00
BiondVax Pharmaceuticals Ltd. today announced that the Israel Investment Center, a unit of the Government of Israel's Ministry of Economy and Industry, approved a grant representing 20% of a NIS 20M budget to be utilized towards the construction of...


29 mars 2017

16:30
Diplomat Pharmacy, Inc. has been selected to the panel for the limited-distribution drug OCREVUStm (ocrelizumab). OCREVUS was approved by the Food and Drug Administration for the treatment of relapsing multiple sclerosis (RMS) and primary...

16:05
QIAGEN N.V. today announced the U.S. launch of its ipsogen® JAK2 RGQ PCR Kit (ipsogen JAK2 assay), which was cleared by the U.S. Food and Drug Administration as a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele...

16:05
Bodycad announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Bodycad Unicompartmental Knee System, enabling the commercial launch of this truly personalized orthopaedic restoration. Bodycad is the...

13:16
Mylan N.V. today commented on the status of its abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) for its generic version of GlaxoSmithKline's Advair Diskus®. In conjunction with Mylan's GDUFA goal date, the...

12:44
Halozyme Therapeutics, Inc. , a biotechnology company developing novel oncology and drug-delivery therapies, today announced that an Oncologic Drug Advisory Committee of the U.S. Food and Drug Administration voted 11 to 0 that the benefit/risk of...

11:00
Providence Medical Technology, Inc., an innovator in tissue-sparing, cervical-fusion technology, announced the addition of two industry veterans to the commercial leadership team.  Scott Lynch has joined the company to lead Global Marketing, and...

09:00
Neurim Pharmaceuticals ("Neurim") and Exeltis announced today a license agreement in which Exeltis will obtain exclusive marketing rights for Neurim's new Rx PedPRM in Spain. Neurim's paediatric prolonged-release Melatonin is an age-appropriate drug...

08:55
SILVER SPRING, Md., March 29, 2017 On March 28, the U.S. Food and Drug Administration approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is...

06:02
Egalet Corporation ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain and other conditions, today announced the U.S. Food and Drug Administration (FDA)...


28 mars 2017

13:50
Regeneron Pharmaceuticals, Inc. and Sanofi will hold a conference call for the financial community to discuss the U.S. Food and Drug Administration approval of DUPIXENT® (dupilumab). The conference call will take place today, March 28, 2017, at 4pm...

11:47
The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies,...

11:40
Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration (FDA) approved DUPIXENT® (dupilumab) Injection, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe...

11:40
Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) Injection, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe...

11:17
Upper extremity amputees are one step closer to successfully picking up a cookie and an egg, thanks to a new advanced prosthetic system that is designed to restore sensation. The U.S. Food and Drug Administration (FDA) has granted an...

10:37
SYNERGY MEDSALES, INC., a global leader in aesthetic device sales, has announced that it has signed an agreement with FormaTK Systems Ltd. to market and distribute their latest FDA-approved laser technologies: "MAGMA," a ND:YAG 1064nm, 808nm Diode, &...


27 mars 2017

16:14
The U.S. Food and Drug Administration today approved Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors...

15:47
TESARO, Inc. , an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved ZEJULAtm (niraparib), an oral, once-daily poly(ADP-ribose) polymerase (PARP) inhibitor, for the maintenance...

08:58
Combined treatment of TyrNovo's NT219 with targeted cancer drugs overcame acquired resistance of colon, lung, and head-and-neck cancers in PDX models Kitov Pharmaceuticals , today announced that TyrNovo Ltd., a company majority-owned by Kitov, will...

08:00
iCAD , an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that PowerLook® Tomo Detection received Premarket Approval (PMA) from the...


23 mars 2017

21:15
Mirabilis Medical, a Seattle-area developer of advanced medical technology for non-invasive surgery, announced today CE Mark authorization for marketing of the Mirabilis System for treatment of uterine fibroids throughout the European Union.  The...

17:30
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) Injection 20 mg/mL, for intravenous...

14:49
The U.S. Food and Drug Administration today granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received...

10:15
Cornerstone Pharmaceuticals, Inc., a clinical-stage, oncology-focused pharmaceutical company, announced a major milestone today.  Following successful End-of-Phase I (EOP1) Type B meetings with the U.S. Food and Drug Administration (FDA), the Company...

08:57
Medicure Inc. ("Medicure" or the "Company") , a leading Canadian specialty pharmaceutical company, is pleased to announce that its majority-owned subsidiary, Apicore Inc., has received final approval from the U.S. Food and Drug Administration (FDA)...

08:30
Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that orphan drug designation has been granted by the European Medicines Agency's (EMA's) Committee for Orphan Medicinal...

08:00
Symbiomix today announced that the US Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for its lead investigational product candidate Solosectm (secnidazole oral granules), an innovative antibiotic...

07:00
BioLineRx Ltd. , a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today that it has acquired Agalimmune Ltd., a private UK-based company with an innovative, anti-cancer immunotherapy platform. Acquisition...


22 mars 2017

09:00
EarlySense, the market leader in Contact-Free Continuous Monitoring solutions, announced today that Newton-Wellesley Hospital, a nationally recognized medical center and a member of Partners Healthcare, has reported a significant improvement in...


21 mars 2017

15:17
The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson's disease who are currently taking levodopa/carbidopa and experiencing "off" episodes. An "off" episode is a time when...

09:00
Tarrex Biopharma, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) application for TX803, a novel treatment for colorectal cancer. "This marks the first significant...


20 mars 2017

13:14
Mylan N.V. , a leading global pharmaceutical company, today announced receipt of tentative approval from the U.S. Food and Drug Administration under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for...

08:00
Trovita Health Science, an emerging life science company specializing in medical nutrition, announces U.S. Food and Drug Administration marketing authorization of the new SAFE-T FEEDtm device for administering tube feeding formulas. The nutrition...

07:31
Allergan plc, , a leading global pharmaceutical company, today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market JUVÉDERM VOLLUREtm XC, for correction of moderate to severe facial wrinkles and...

07:00
- Results to date confirm that single injection of BL-8040 mobilizes sufficient amounts of cells required for allogeneic transplantation without need for G-CSF -  - Top-line results expected by end of 2017 -  BioLineRx Ltd. , a clinical-stage...


16 mars 2017

10:00
Itamar Medical Ltd. reports that AASM, the leading medical association of sleep medicine physicians in the United States, has published an updated version of its Clinical Practice Guideline for Diagnosis of Sleep Apnea that includes the company's...

02:00
CINRYZE is now the first and only Hereditary angioedema treatment approved for routine prevention in paediatrics  Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the European Commission (EC) has approved a label extension granting three new...


15 mars 2017

08:40
First Ray, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for new additions to the Stealth Stapletm System...


14 mars 2017

17:29
PRESS RELEASE - CORRECTION   Positive scientific opinion under Early Access to Medicines Scheme (EAMS) recognises burden of severe atopic dermatitis and the significant unmet need of patients  Sanofi, and its specialty care global...

13:27
Patients suffering from rare blood disorders will benefit from networks of excellence across the European Member States.   At the third conference on European Reference Networks (ERNs) yesterday in Vilnius, Lithuania, EuroBloodNet was officially...

12:54
Yesterday, U.S. District Judge Marcia S. Krieger for the U.S. District Court for Colorado entered a consent decree of permanent injunction against EonNutra LLC, CDSM LLC and HABW LLC, manufacturers and distributors of unapproved drugs and dietary...

04:30
Positive scientific opinion under Early Access to Medicines Scheme (EAMS) recognises burden of severe atopic dermatitis and the significant unmet need of patients  Sanofi, and its specialty care global business unit, Sanofi Genzyme,...


13 mars 2017

15:56
The US Food and Drug Administration (FDA) has approved Kisqali® (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor...

13:00
Conavitm Medical Inc. (conavi.com) announced the approval from Health Canada to market the Foresight ICE System.  Intracardiac echocardiography (ICE) provides physicians with the ability to visualize cardiovascular anatomy and devices during...

09:38
At this time, most sequencing tests performed for clinical applications in the U.S. are laboratory developed tests (LDTs), according to Kalorama Information, meaning that the serviced is performed by test manufacturer and results sent to lab.  But...

09:30
BiondVax Pharmaceuticals Ltd. ,  a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, reports the publication this week of an article by BiondVax-affiliated authors titled,...