News Releases
FDA Approval
The latest news regarding FDA applications, processes, and approval. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions, and safety alerts.
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Sep 17, 2013, 11:34 ET
Syneron Medical recibe la aprobación de la FDA para la reducción circunferencial abdominal y la marca CE para la nueva plataforma VelaShape® III
Syneron Medical Ltd. (NASDAQ: ELOS), líder global en el mercado de dispositivos médicos estéticos, anunció la... -
Sep 17, 2013, 10:34 ET
Syneron Medical recibe la aprobación de la FDA para la reducción circunferencial abdominal y la marca CE para la nueva plataforma VelaShape® III
En un estudio clínico realizado a 42 pacientes, se consiguió una media en la reducción de la circunferencia abdominal de 2,6... -
Sep 17, 2013, 06:00 ET
Boehringer Ingelheim's investigational volasertib receives FDA Breakthrough Therapy designation
Boehringer Ingelheim Pharmaceuticals, Inc. today announced the FDA has granted Breakthrough Therapy designation to volasertib*, an investigational... -
Sep 16, 2013, 13:34 ET
Vital Access Corp Announces FDA Clearance Of VWING™ Vascular Needle Guide
Vital Access Corp. today announced that it has received U.S. Food and Drug Administration (FDA) market clearance for its patented VWING™... -
Sep 16, 2013, 10:04 ET
Zubsolv® Now Available in the U.S. for the Maintenance Treatment of Opioid Dependence
Orexo U.S. announced today that Zubsolv (buprenorphine and naloxone) sublingual tablets (CIII) are commercially available in pharmacies across... -
Sep 16, 2013, 08:30 ET
InspireMD Appoints David Blossom as Vice President of Global Marketing and Strategy
InspireMD Inc. (NYSE MKT: NSPR) ("InspireMD" or the "Company"), a leader in embolic protection stents, today announced the appointment of... -
Sep 16, 2013, 08:00 ET
NeoTract, Inc. Receives U.S. FDA De Novo Approval for the UroLift® Prostate Implant
NeoTract, Inc., today announced that it received De Novo approval from the U.S. Food and Drug Administration (FDA) to market the novel... -
Sep 16, 2013, 08:00 ET
Quidel Receives Two FDA Clearances For Molecular Diagnostic Tests For Use On Life Technologies QuantStudio™ Dx
Quidel Corporation (NASDAQ: QDEL) and Life Technologies Corporation (NASDAQ: LIFE) announced today that the United States Food and Drug... -
Sep 16, 2013, 04:00 ET
Nova Plataforma VelaShape® III recebe autorização da FDA para a Redução do Perímetro Abdominal e marcação CE
Num ensaio clínico realizado em 42 pacientes, foi alcançada uma redução média de 2,6 cm do perímetro abdominal... -
Sep 12, 2013, 06:48 ET
Syneron Medical reçoit l'agrément de la FDA pour la réduction de la circonférence abdominale ainsi que le marquage CE pour sa nouvelle plateforme VelaShape® III
Lors d'une étude clinique sur quarante-deux patients, une réduction moyenne de la circonférence abdominale de 2,6 cm a... -
Sep 11, 2013, 19:01 ET
Se comercializa en Rusia Halaven® (eribulina), el primer y único tratamiento en monoterapia que aumenta la supervivencia en el último estadio del cáncer de mama metastásico
Los resultados del estudio EMBRACE proporcionan la base para la autorización Halaven® (eribulina) está ya disponible en Rusia como... -
Sep 11, 2013, 19:01 ET
Halaven® (eribulin), die erste und einzige lebensverlängernde Mono-Chemotherapie bei metastasiertem Brustkrebs im spätstadium, jetzt in Russland erhältlich
Ergebnisse der EMBRACE-Studie liefern die Grundlage für die Zulassung Halaven® (Eribulin) ist nun in Russland als neue... -
Sep 11, 2013, 12:36 ET
Syneron Medical riceve l'approvazione della FDA per la riduzione della circonferenza addominale e il marchio CE per la nuova piattaforma VelaShape® III
In uno studio clinico su quarantadue pazienti, si è ottenuta una riduzione di 2,6 cm della circonferenza addominale media con un solo... -
Sep 11, 2013, 10:00 ET
Ventana receives approval from China's FDA for first fully automated IHC companion diagnostic identifying ALK protein expression in lung cancer patients
Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, today announced the approval of the VENTANA ALK immunohistochemistry... -
Sep 11, 2013, 09:00 ET
Syneron Medical erhält FDA-Freigabe für die Verringerung des Bauchumfangs und die CE-Zulassung für die neue VelaShape® III Plattform
In einer klinischen Studie mit 42 Patienten wurde nach einer einmaligen Behandlung nach dem VelaShape III-Protokoll eine durchschnittliche... -
Sep 11, 2013, 09:00 ET
Syneron Medical Receives FDA Clearance for Abdominal Circumferential Reduction and CE mark for the New VelaShape® III Platform
In a clinical study of forty-two patients, an average abdominal circumference reduction of 2.6 cm was achieved following a single... -
Sep 11, 2013, 08:00 ET
Syndax's Entinostat Receives Breakthrough Therapy Designation from FDA for Treatment of Advanced Breast Cancer
Syndax Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated entinostat as a... -
Sep 11, 2013, 08:00 ET
Rehrig Pacific Company Receives FDA Approval for New Reusable Sharps Container
Rehrig Healthcare, a division of Rehrig Pacific Company, today announced that its SharpsTank® Reusable Sharps Container Model TS received... -
Sep 10, 2013, 16:28 ET
IntelligentMDx Receives FDA Clearance for IMDx Flu A/B and RSV for Abbott m2000 assay
IntelligentMDx announced today that the U.S. Food and Drug Administration (FDA) has cleared its automated molecular diagnostic test that... -
Sep 10, 2013, 09:29 ET
Perrigo Company Announces FDA Final Approval For The Store Brand Equivalent To Children's Zyrtec® Allergy Syrup, 1 mg/mL
Perrigo Company (NYSE: PRGO; TASE) today announced that it has received final approval from the U.S. Food and Drug Administration for its...
