Le Lézard

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

7 avril 2017

10:56
The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved...

09:00
Medizone International, Inc. announced that in a scheduled conference call late Thursday, April 6, 2017, with representatives of the U.S. Food and Drug Administration ("FDA"), the FDA had advised the Company that they believed AsepticSure should be...

01:00
Intralytix, Inc. announced today that its latest food safety product, ShigaShieldtm, has received GRAS (Generally Recognized As Safe) recognition from the Food and Drug Administration (FDA). ShigaShieldtm is a non-chemical antimicrobial preparation...


6 avril 2017

12:38
Joylux debuts vSculpt®, a revolutionary device to address the discomfort and embarrassment suffered by millions of women with pelvic floor issues Today in London, Joylux launched vSculpt, a world first: a home-use medical device using a unique...

12:11
23andMe, Inc., the leading personal genetics company, today announced that the U.S. Food and Drug Administration (FDA) granted the company the first authorization to market genetic reports on personal risk for certain diseases. The authorization...

08:00
(Booth #300) ? iCAD , an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced the Company will highlight PowerLook® Tomo Detection, an...

07:30
Valeant Pharmaceuticals International, Inc.'s wholly owned subsidiary, Bausch + Lomb, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Stellaris Elitetm Vision Enhancement System, the...

07:00
Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to evinacumab for the treatment of hypercholesterolemia in patients with Homozygous Familial...

06:59
BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a flow cytometer system with a leucocount reagent assay used in...


5 avril 2017

20:00
A first-of-its-kind Indian biotechnology  company, APAC Biotech, was granted with a commercial license by Indian FDA (CDSCO - Central Drugs Standard Control Organization) to market product, APCEDEN®, a Dendritic cell-based autologous Immuno-oncology...

08:00
A first-of-its-kind Indian biotechnology company, APAC Biotech, was granted with a commercial license by Indian FDA (CDSCO - Central Drugs Standard Control Organization) to market product, APCEDEN®, a Dendritic cell-based autologous Immuno-oncology...


4 avril 2017

20:00
JHL Biotech Inc. (Stock Code: 6540.TWO) is announcing that its Clinical Trial Application ("CTA") for use of JHL1101 in Phase 1 and Phase 3 clinical trials in Non-Hodgkin's Lymphoma patients has been accepted by the China Food and Drug Administration...

15:56
Protein Sciences Corporation, maker of Flublok® Influenza Vaccine, announced that FDA approved an extended shelf life for Flublok Quadrivalent from 6 months to 9 months ensuring that Flublok can be used throughout the flu season. Trivalent Flublok...

12:42
AirXpanders, Inc. (ASX: AXP) (AirXpanders or Company), a medical device company focused on the design, manufacture, sale and distribution of the AeroForm® Tissue Expander System, is today providing an update on its full U.S. commercial launch of...

10:00
VivaLnk, a Silicon Valley startup and the inventor of eSkintm technology, today announced that Fever Scouttm, a soft, wearable thermometer that continuously measures temperature, has received 510(k) clearance from the Federal Drug Administration and...


3 avril 2017

13:36
In a recent meeting between the Wockhardt Research team and the US FDA New Drug Antibiotic Regulatory team, the US FDA agreed to an abridged Phase III clinical trial for Wockhardt's superdrug antibiotic WCK 5222. This was based on the evaluation by...

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)...

02:15
Kitov Pharmaceuticals Holdings Ltd. , an innovative biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Kitov a waiver related to the $2,038,100 New Drug Application (NDA 210045) filing fee for...


30 mars 2017

12:43
Bodycad a annoncé aujourd'hui avoir reçu l'approbation 510(k) du Secrétariat américain aux produits alimentaires et pharmaceutiques (FDA) pour sa prothèse personnalisée unicompartimentale du genou, permettant le lancement commercial de la...

12:40
RenovoRx, manufacturer of the RenovoCath adjustable dual-balloon infusion catheter, today, announced it has received FDA 510(k) clearance to expand its indications for use to include the 'delivery of chemotherapeutics'. The RenovoCath device isolates...

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...

12:28
Market research firm Kalorama Information notes two big developments in sepsis detection and diagnosis last month. The firm, which has a specialty in IVD markets and life science markets, said that a new qPCR test and a PCT biomarker test were...

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...

08:30
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...