Cook Medical has introduced a new venous self-expanding stent in Canada, designed to restore blood flow in obstructed iliofemoral veins caused due to post-thrombotic syndrome (PCT). The Zilver Vena stent, which is compatible with 7 Fr ...
Tags: Cook Medical, self-expanding stent, PCT, Zilver Vena stent
NuVasive has gained premarket approval (PMA) for its cervical motion preserving system from the US Food and Drug Administration (FDA). The PCM cervical disc device, which is comprised of superior and inferior endplates, is designed for ...
Tags: cervical motion preserving system, PCM cervical disc device, FDA
Pfizer and Ligand Pharmaceuticals have announced the FDA acceptance of bazedoxifene/conjugated estrogens (BZA/CE) new drug application (NDA) for review. The BZA/CE is an investigational therapy developed by Wyeth Pharmaceuticals to tackle ...
Tags: estrogens NDA, Pharmaceuticals, FDA, menopausal symptoms
The US Food and Drug Administration (FDA) has cleared Boston Scientific's subcutaneous implantable cardioverter defibrillator (S-ICD) to treat patients at risk for sudden cardiac arrest (SCA). The CE-marked system, which the company ...
Tags: FDA, CE-marked system, S-ICD system
Moximed has implanted the first patient with its KineSpring system in a prospective, single-arm clinical US study. The study, named SOAR, will enroll 30 patien,,ts to evaluate the safety and efficacy of the medical spring system in the ...
Tags: Moximed, patient, KineSpring system
US based NuPathe announced that its New Drug Application (NDA) resubmission for its migraine patch (NP101) has been accepted for filing by the US Food and Drug Administration (FDA). Migraine Patch (NP101 or Zelrix) is an active, ...
Tags: FDA, NuPathe, migraine patch, NDA
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional approval for Takeda Pharmaceuticals and Millennium adcetris (brentuximab vedotin) in Europe. If the CHMP ...
Tags: CHMP, refractory CD30 positive Hodgkin lymphoma, sALCL
Gilead Sciences has received US Food and Drug Administration (FDA) approval for Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Stribild is a complete once-daily single tablet ...
Abbott will expand the current CE-IVD product labeling for its Vysis ALK Break Apart FISH Probe Kit to allow the test to be marketed in the European Union as a companion diagnostic. The test uses Abbott's proprietary fluorescence in situ ...
Tags: Abbott, anaplastic lymphoma kinase, ALK, FISH technology
Pfizer is considering buying NextWave Pharmaceuticals, a company that develops a liquid attention deficit hyperactivity disorder drug. In the second quarter of 2012, Pfizer signed an option and merger agreement with NextWave and made a ...
Tags: Pfizer, NextWave Pharmaceuticals, deficit hyperactivity disorder drug
Medivation and Astellas Pharma have launched Xtandi (enzalutamide) capsules for patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. Xtandi, an oral, once-daily androgen receptor inhibitor ...
Aptalis Pharma, a specialty pharmaceutical company, has announced the commercial availability of Viokace (pancrelipase) tablets in the US. Viokace, in combination with a proton pump inhibitor, is indicated in adults for the treatment of ...
Cell Therapeutics (CTI) has announced the European launch of Pixuvri for the treatment of adult patients with multiply relapsed or refractory aggressive non-hodgkin B-cell lymphoma. The company initiated the launch with entry into Sweden, ...
Tags: Cell Therapeutics, Pixuvri, NHL, B-cell lymphoma
Zogenix has commenced first IND clinical trial for Relday in patients with chronic, stable schizophrenia or schizoaffective disorder. Relday is based on a combination of its DosePro needle-free, subcutaneous drug delivery system with a ...
Tags: Clinical Trial, DosePro needle-free drug, pharmacokinetic
DARA BioSciences has launched a liquid version of tamoxifen under the brand name Soltamox in the US Tamoxifen Citrate is the most common drug prescribed to treat breast cancer. Soltamox is expected to offer treatment option for patients ...
Tags: tamoxifen, Soltamox, breast cancer