Le Lézard

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

7 mars 2017

11:00
Beckman Coulter Diagnostics announces FDA clearance and U.S. commercial launch of its new DxC 700 AU chemistry analyzer. The new system brings together the advanced capabilities of two successful Beckman Coulter products ? the simple intuitive design...

10:00
Intellijoint Surgical® Inc., a privately-held Canadian medical technology company, announces FDA clearance of intellijoint HIP® Anterior, the newest application to the intellijoint HIP suite. intellijoint HIP Anterior is a 3D mini-optical navigation...

09:00
Worldwide Clinical Trials (http://www.worldwide.com) and Bellerophon Therapeutics (http://www.bellerophon.com) have been selected as finalists in the 2017 Clinical Research & Excellence (CARE) Awards in the "Clinical Partnership of the Year"...

03:11
Swedish Orphan Biovitrum AB (publ) (Sobitm) today announces that FDA has approved in-use storage at room temperature (25°C or less) for up to 45 days for all strengths of Orfadin® capsules (2 mg, 5 mg, 10 mg and 20 mg). The FDA approval follows the...


6 mars 2017

13:55
Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in rare diseases and highly specialized conditions, will present data assessing primary immunodeficiency (PI) patient treatment satisfaction with CUVITRU [Immune Globulin Subcutaneous (Human), 20%...

08:00
PTC Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the filing over protest of PTC's New Drug Application (NDA) for Translarnatm (ataluren), an oral, first-in-class, protein restoration therapy...

08:00
The first patient in Los Angeles to receive the recently FDA-approved corneal cross-linking (CXL) procedure to help prevent blindness from keratoconus, was recently treated by experts at the University of Southern California (USC) Roski Eye...

08:00
Teligent, Inc. , a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) of Triamcinolone...


3 mars 2017

15:05
The U.S. Food and Drug Administration today approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night)....

09:00
The 16th annual global food safety conference proved to be record-breaking on several dimensions. Nearly 1200 delegates from 54 countries trekked to Houston, TX to collaborate, resulting in record-breaking attendance to focus on the conference's...

08:22
La 16e Conférence mondiale annuelle sur la sécurité alimentaire a démontré qu'elle pouvait battre des records à plusieurs égards. Près de 1 200 délégués originaires de 54 pays ont convergé vers Houston, au Texas, à des fins de coopération, ce qui...


2 mars 2017

15:34
Truth Initiative and the Campaign for Tobacco-Free Kids today criticized as wholly inadequate an agreement reached between the Food and Drug Administration (FDA) and Santa Fe Natural Tobacco Company, the makers of Natural American Spirit cigarettes,...

08:03
EnGeneIC Ltd., a clinical stage biopharmaceutical company focused on developing its proprietary EDVtm nanocell platform for targeted cyto-immunotherapy in cancer, announced that U.S. Food and Drug Administration (FDA) has granted Orphan Drug...

07:00
Compugen Ltd. , a leading therapeutic discovery company, announced today that two abstracts, the first covering data of its lead pipeline product and another on its predictive discovery methodologies for novel immune checkpoints, will be presented as...

02:41
Swedish Orphan Biovitrum AB (publ) (Sobitm) (STO:SOBI) has received approval from the European Medicines Agency (EMA) for the grouped type II 15 K Variation for Elocta® (efmoroctocog alfa). The variation involves several changes, including the...


1 mars 2017

18:36
ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet.      (Logo:...

17:22
The U.S. Food and Drug Administration today approved Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis), with or without eye...

08:55
Perrigo Company plc today announced it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application referencing Eli Lilly and Company's Axiron® Topical Solution, 30 mg/1.5 mL (Testosterone Topical...

08:30
Sangamo Therapeutics, Inc. , the leader in therapeutic genome editing, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SB-913, a genome editing product candidate for the treatment of...

06:20
L'Initiative mondiale pour la sécurité alimentaire (IMSA) a tenu aujourd'hui une conférence de presse afin de lancer la 16[e] Conférence internationale sur la sécurité alimentaire, d'annoncer la publication d'une nouvelle édition des critères de...


28 février 2017

19:00
WuXi AppTec, a leading global pharmaceutical, biotechnology and medical device open-access capability and technology platform company, today announced that its Lab Testing Division(LTD)'s Bioanalytical facility in Shanghai once again passed US FDA's...

16:56
The U.S. Food and Drug Administration today approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately...

15:56
Lexicon Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved XERMELOtm (telotristat ethyl) 250 mg as a first and only orally administered therapy for the treatment of carcinoid syndrome diarrhea in...

14:50
The Global Food Safety Initiative (GFSI) today held a press conference to launch the 16th Global Food Safety Conference, announce the release of a new edition of GFSI's flagship Benchmarking Requirements and to share groundbreaking strides in...

09:00
The American College of Radiology (ACR) published updated guidelines (Feb. 19, 2017) regarding the NEMA XR-29 (MITA Smart Dose) Standard, finally setting a clear and specific set of guidelines for an acceptable Certificate of NEMA XR-29 Compliance....

08:00
IRIDEX Corporation is pleased to announce the availability of the G-Probetm Illuminate, a new, FDA-cleared probe offering combined transillumination and laser fiber for targeted transscleral cyclophotocoagulation (CPC). The G-Probe Illuminate marks...

07:00
Second Biologics License Application accepted by the FDA for avelumab  Prognosis for urothelial carcinoma is currently poor, particularly when the disease has metastasized   EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt,...


27 février 2017

11:30
Announces Fourth Quarter and Full Year 2016 Financial Highlights, including Record Revenue and $133.2 million in Backlog ViewRay, Inc.  announced today that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to...

08:30
RegeneRx Biopharmaceuticals, Inc. ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that its licensee for RGN-137, GtreeBNT Co., Ltd., received a positive...

08:00
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced the U.S. Food and Drug Administration (FDA) approved VARIBAR PUDDING for modified barium swallow (MBS)...

08:00
Royal Philips , a global leader in health technology, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ElastQ Imaging capability, further expanding the functionalities of its EPIQ family of ultrasound...

06:01
OncoSec Medical Incorporated ("OncoSec") , a company developing DNA-based intratumoral cancer immunotherapies, received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its ImmunoPulse® IL-12, a potentially first-in-class,...

01:30
Valeant Pharmaceuticals International, Inc.'s wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for latanoprostene...


24 février 2017

08:03
Not intended for U.S. and UK based media  Ready-to-use pre-filled pen provides a convenient treatment option for patients  Simplified injection device for self-administration comes in multiple doses, addressing individual needs of patients ...


23 février 2017

17:30
The U.S. Food and Drug Administration today cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, such...

09:00
Could potentially shorten study period by more than six months E-QURE Corp. , a leader in medical devices for the treatment of advanced wound care, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to...

08:00
Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced the U.S. Food and Drug Administration (FDA) has granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of patients with recurrent high grade...

07:30
Novartis today announced that the US Food and Drug Administration (FDA) accepted the Company's supplemental New Drug Application (sNDA) for filing, and granted Priority Review for the expanded use of Zykadia® (ceritinib) as a first-line treatment for...

07:00
Resverlogix Corp. ("Resverlogix" or the "Company") today announced the receipt of the final minutes of an in-person Type B meeting with the Cardiovascular and Renal Products Division of the U.S. Food and Drug Administration (FDA). The purpose of the...

07:00
BioLight Life Sciences Ltd. ("BioLight"), an emerging global ophthalmic company focused on the discovery, development and commercialization of products and product candidates which address ophthalmic conditions, announced today that, DiagnosTear...

00:01
Seventh Sense Biosystems, Inc. (7SBio) announced today that a new blood collection device called TAP has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The technology represents a landmark innovation in the blood collection...


22 février 2017

08:00
Immunexpress, Inc., a molecular diagnostic company committed to improving outcomes for suspected sepsis patients and healthcare providers, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the use...

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...