The US Food and Drug Administration (FDA) has accepted to review AstraZeneca's new drug application (NDA) for Epanova, an investigational compound for the treatment for patients with severe hypertriglyceridaemia. Omthera Pharmaceuticals, ...
Global clinical technology solutions provider Trifecta Clinical and SAFE-BioPharma have entered into a strategic partnership to promote use of standards-based digital identities. Under the deal, Trifecta will implement SAFE-BioPharma's ...
US-based Crosstrees Medical has obtained 510(k) approval from the US Food and Drug Administration (FDA) for the Crosstrees PVA pod system for percutaneous vertebral augmentation (PVA). The FDA approval for the CE marked Crosstrees PVA pod ...
PolyNovo Biomaterials, a wholly-owned subsidiary of Calzanda, has filed 510(k) application with the US Food and Drug Administration (FDA) for an approval to market its NovoSorb wound dressing in topical negative pressure (TNP) wound ...
Quidel has obtained the US Food and Drug Administration (FDA) approval for two infectious disease tests that run on Life Technologies' QuantStudioDx instrument. Life Technologies' QuantStudioDx instrument offers the advanced capabilities ...
Tags: Diagnostic Tests, Quidel
US-based medical device company Neuros Medical has obtained an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for its Altius, an implantable generator that delivers high frequency Electrical ...
Tags: Implantable Generator, Medicine
Vital Access, a manufacturer of surgical and interventional technologies, has secured the US Food and Drug Administration (FDA) market approval for its VWING device, a vascular needle guide developed to enable vascular access to ...
Tags: Vital Access, VWING device
Siemens Healthcare Diagnostics, a provider of clinical diagnostics and therapeutic systems, has voluntarily recalled its MicroScan Synergies plus negative and rapID/S plus negative panels, which are used to determine the antimicrobial ...
US-based orthopedics services provider Dallen Medical has filed 510(k) application with the US Food and Drug Administration (FDA) for individually packaged, sterile Compressyn staple implants. The Compressyn staple implant delivers ...
Tags: Compressyn Staple Implant, Health, Medicine
The European Medicines Agency (EMA) has granted an orphan drug status to US-based clinical-stage biotechnology company GlycoMimetics' GMI-1070 (rivipansel sodium), designed to treat vaso-occlusive crisis (VOC) in patients with sickle cell ...
The European Medicines Agency (EMA) has granted an orphan drug status to US-based clinical-stage biotechnology company GlycoMimetics’ GMI-1070 (rivipansel sodium), designed to treat vaso-occlusive crisis (VOC) in patients with sickle ...
Tags: Orphan Drug, Cell Drug
US-based pharmaceutical manufacturer and marketer Forest Laboratories (FRX) has received qualified infectious disease product (QIDP) designation for its ceftazidime/avibactam drug from the US Food and Drug Administration (FDA). Currently ...
Tags: drug, Forest Laboratories
The US Food and Drug Administration (FDA) has approved breakthrough therapy designation for Danish biotechnology company Genmab and British pharmaceutical company GlaxoSmithKline’s (GSK) Arzerra (ofatumumab) in combination with ...
Tags: therapy designation, Medicine
NeoTract has received an approval from the US Food and Drug Administration (FDA) to market its UroLift system, designed to relieve low or blocked urine flow in men age 50 and older with an enlarged prostate (benign prostatic hyperplasia). ...
Tags: Prostate Implant, Neotract
Schwebel Baking has recalled 18,979 units of Golden Rich Buns with Honey, as they contain egg which is not mentioned on the labeling, according to the US Food and Drug Administration (FDA). The product subject to recall is Golden Rich ...
Tags: Schwebel, Golden Rich Buns