Le Lézard

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

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25 septembre 2017

08:00
NESS ZIONA, Israel and CHAPEL HILL, North Carolina, Sept. 25, 2017 /PRNewswire/ -- Atox Bio today announced that it has been awarded the next option on a performance-based contract with the Biomedical Advanced Research and Development Authority...

07:00
MARLBOROUGH, Mass., Sept. 25, 2017 /PRNewswire/ -- Boston Scientific (NYSE: BSX) has launched the Resonatetm family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems featuring the...

06:30
Prometic procède immédiatement à la formalisation du recrutement des sites cliniques des spécialistes aux États-Unis La demande d'un nouveau médicament de recherche sera suivie de demandes d'études cliniques au Canada, en Europe, en Australie et au...

06:30
Prometic moving immediately to formalize enrollment of specialist clinical sites across the United States U.S. IND to be followed by clinical trial applications in Canada, Europe, Australia and Japan throughout Q4 2017 Prometic plans to supplement...

06:30
MALVERN, Pa., Sept. 25, 2017 /PRNewswire/ -- Ocugen, Inc., a clinical stage biopharmaceutical company developing novel treatments for sight-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its...


22 septembre 2017

08:00
ABBOTT PARK, Ill., Sept. 22, 2017 /PRNewswire/ -- Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for one of Abbott's most widely-used implantable cardioverter...


21 septembre 2017

09:29
DUBLIN, Sept. 21, 2017 /PRNewswire/ -- Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing Exalgo® 32mg...

09:00
NEW YORK, Sept. 21, 2017 /PRNewswire/ -- CEFALY Technology announces today that on Friday, September 15th, the U.S. Food and Drug Administration (FDA) released the use of a new Cefaly® medical device for the acute treatment of migraine, with or...

03:13
DARMSTADT, Germany and NEW YORK, USA, September 21, 2017 /PRNewswire/ -- Not intended for UK-based media       First approved immunotherapy for rare and aggressive skin cancer in the European Union, with initial launches planned in Germany...


20 septembre 2017

14:07
SEATTLE, Sept. 20, 2017 /PRNewswire/ -- PhaseRx, Inc. (NASDAQ: PZRX), a biopharmaceutical company developing mRNA treatments for life-threatening inherited liver diseases in children, today announced that its second drug development candidate,...


19 septembre 2017

12:30
RIVIERA BEACH, Fla., Sept. 19, 2017 /PRNewswire/ -- Sancilio Pharmaceuticals Company, Inc. (SPCI) today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to Altemiatm Soft Gelatin Capsules for...

11:16
KNOXVILLE, Tenn., Sept. 19, 2017 /PRNewswire/ -- Arkis BioSciences, a leading innovator in minimally invasive surgical instrumentation, has obtained FDA clearance of its new external ventricular drainage catheter, CerebroFlotm.  According to Chad...

08:30
DUBLIN, Sept. 19, 2017 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") today highlighted that the US Food and Drug Administration (FDA) has approved Trelegy Ellipta, the triple combination therapy of fluticasone...


18 septembre 2017

23:20
LUND, Suède, September 19, 2017 /PRNewswire/ -- La FDA a fixé une date butoir en vertu de la PDUFA au 19 janvier 2018 pour la demande d'autorisation de l'injection de dépôts hebdomadaires et mensuels de buprénorphine dans le cadre du traitement de...

20:30
LONDON, Sept. 18, 2017 /PRNewswire/ -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the US Food and Drug Administration (FDA) has approved once-daily, single inhaler triple therapy fluticasone...

10:07
EDINA, Minn., Sept. 18, 2017 /PRNewswire/ -- U.S. ARKRAY, Inc. (ARKRAY) announces the launch of the ADAMStm A1c HA-8180V System for hemoglobin A1c testing. The system obtained FDA 510(k) clearance as an aid in the diagnosis and monitoring of...

08:45
DUBLIN, Sept. 18, 2017 /PRNewswire/ -- Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Acanya® (clindamycin phosphate and benzoyl...

08:15
PALO ALTO, Calif., Sept. 18, 2017 /PRNewswire/ -- Varian Medical Systems (NYSE: VAR) today announced the newest release of its treatment planning system, Eclipse 15.5. This new release has received FDA 510(k) clearance, and incorporates several new...

08:00
VANCOUVER, British Columbia, and MENLO PARK, Calif., Sept. 18, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" and "the Company"), a biopharmaceutical company focused on the development of new cancer therapies, today...

07:30
SUGAR LAND, Texas, Sept. 18, 2017 /PRNewswire/ -- Researched by Annette Kreuger, Industrial Info Resources --Biological drug maker Genentech, the developer of the blockbuster cancer drug Avastin, was dealt a stunning blow on September 14 when the...

04:17
LUND, Sweden, September 18, 2017 /PRNewswire/ -- The FDA has assigned a PDUFA target date of January 19, 2018   Camurus (NASDAQ STO: CAMX) announces that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for...


15 septembre 2017

01:00
ATLANTA and BRUSSELS, Sept. 15, 2017 /PRNewswire/ -- UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for BRIVIACT® (brivaracetam) CV as monotherapy for partial-onset (focal)...


14 septembre 2017

19:50
KING OF PRUSSIA, Pa., Sept. 14, 2017 /PRNewswire/ -- Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved Privigen® [Immune Globulin Intravenous (Human), 10% Liquid] for the treatment...

17:10
WHIPPANY, N.J., Sept. 14, 2017 /PRNewswire/ -- Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Aliqopatm (copanlisib) for the treatment of adult patients with relapsed FL who have received at least two prior...

16:33
BOSTON and SAN FRANCISCO, Sept.14, 2017 /PRNewswire/ -- Pear Therapeutics, the leader in a new era of prescription digital therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Pear's De Novo request, allowing the...

15:55
Journalists and other readers should disregard the news release, Pear Therapeutics Obtains FDA Clearance of the First Prescription Digital Therapeutic to Treat Disease, issued 14-Sep-2017. An incorrect version was released by PR Newswire...

14:54
THOUSAND OAKS, Calif., Sept. 14, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved MVASItm (bevacizumab-awwb) for all eligible indications of the...

14:23
BOSTON, and SAN FRANCISCO, Sept. 14, 2017 /PRNewswire/ -- Pear Therapeutics, the leader in a new era of prescription digital therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Pear's De Novo request, allowing...

13:58
SILVER SPRING, Md., Sept. 14, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least...

12:45
SILVER SPRING, Md., Sept. 14, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first...

10:45
SILVER SPRING, Md., Sept. 14, 2017 /PRNewswire-USNewswire/ -- Today, the U.S. Food and Drug Administration permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). The Reset application is intended to...

08:30
RARITAN, N.J., Sept. 14, 2017 /PRNewswire/ -- Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, has received approval from  the U.S. Food and Drug Administration (FDA) for Ortho's VITROS® Immunodiagnostic Products...


13 septembre 2017

15:53
LEXINGTON, Mass., Sept. 13, 2017 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that GlaxoSmithKline's (GSK) shingles vaccine candidate,...

15:49
LONDON, Sept. 13, 2017 /PRNewswire/ -- GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted unanimously that the data...


12 septembre 2017

22:00
TOKYO, Sept. 12, 2017 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application...

11:35
MUNDELEIN, Ill., Sept. 12, 2017 /PRNewswire/ -- Douglas Medical Products, Inc., a growing medical device company focused on contract manufacturing of IV Administration/Extension Sets and Enteral (ENFit) Sets, announced today that it has received...

09:09
BOULDER, Colo., Sept. 12, 2017 /PRNewswire/ -- Array BioPharma (Nasdaq: ARRY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Applications (NDAs) to support use of the combination of binimetinib...

08:34
PHOENIX, Sept. 12, 2017 /PRNewswire/ -- SmartPractice has received FDA approval for T.R.U.E. TEST (truetest.com) ready-to-use patch test panels for pediatric patients as young as 6 years of age. T.R.U.E. TEST is the only FDA-approved product for...


11 septembre 2017

06:57
DARMSTADT, Germany, September 11, 2017 /PRNewswire/ -- Not intended for U.K. based media   Big data platform to help accelerate innovative discovery, development and delivery of new approaches in cancer care   Enhanced analytical capabilities...

01:00
LEIDEN, The Netherlands, September 11, 2017 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) announced today that it has concluded its End-of-Phase 2 interactions with the U.S. Food and Drug...


8 septembre 2017

01:00
TARRYTOWN, N.Y. and PARIS, Sept. 8, 2017 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation status to cemiplimab...


7 septembre 2017

14:18
NEW YORK, Sept. 7, 2017 /PRNewswire/ -- Assured Bites, Inc., a New York-based family health and wellness company on the forefront of peanut allergy prevention, is pleased to announce the U.S Food and Drug Administration (FDA) has approved its...

08:00
FT. LAUDERDALE, Fla., Sept. 7, 2017 /PRNewswire/ --  Spinal Resources, Inc.® (SRI) announced that it has received FDA 510(k) clearance for its Swedgetm Pedicle Screw System. This unique system offers multiple benefits, including CoCr and Titanium...

07:00
LOS ANGELES, Sept. 7, 2017 /PRNewswire/ -- Global Health Solutions, a leader in innovative solutions for advanced wound care and dermatology, has announced filing of its 510(k) application for an antimicrobial advancement upon traditional petroleum...

07:00
MISSISSAUGA, ON, Sept. 7, 2017 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) ("Cipher" or "the Company") today commented on a warning letter issued to Cipher by the Office of Prescription Drug Promotion of the U.S. Food and Drug Administration...


6 septembre 2017

08:32
WILMINGTON, Del., Sept. 6, 2017 /PRNewswire/ -- NeuroRx, a clinical stage biopharma company developing the first oral therapy for Acute Suicidal Ideation and Behavior (ASIB), has been granted Fast Track status by the US Food and Drug Administration...

08:00
SAN DIEGO, Sept. 6 2017 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has received 510(k)...

08:00
SOUTH SAN FRANCISCO, Calif., Sept. 6, 2017 /PRNewswire/ -- Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that the U.S. Food and Drug Administration (FDA) has approved a new 32 mg...


5 septembre 2017

14:00
HOUSTON, Sept. 5, 2017 /PRNewswire/ -- C4 Imaging LLC is pleased to announce an additional US Food and Drug Administration 510(k) clearance for its Siriustm MRI Marker, a novel positive-signal MRI Marker that is used during the treatment of prostate...

13:47
PRINCETON, N.J., Sept. 5, 2017 /PRNewswire/ -- Guerbet LLC USA, the US affiliate of the global specialist in contrast products and solutions for medical imaging, announced today that the US Food and Drug Administration (FDA) has approved Dotarem®...

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