Biotechnology firm Alexion Pharmaceuticals has secured approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the use of its Soliris (eculizumab) drug to treat pediatric and adult patients with atypical hemolytic ...
Tags: Ahus Treatment, Soliris 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
Dfine, a manufacturer of spinal disease treatment devices, has obtained CE Mark approval for its STAR tumor ablation system, designed to treat painful metastatic spinal tumors. The STAR tumor ablation system uses radiofrequency (RF) ...
Tags: Dfine, Tumor Ablation System
CAS Medical Systems (CASMed), a medical technology company, has announced the initial sales of its next-generation Fore-Sight Elite cerebral oximetry products. The Fore-Sight Elite is lighter and more portable than the earlier model, with ...
Noble Biomaterials, Inc. announced a global strategic alliance with lululemon athletica canada Inc. The partnership gives lululemon exclusivity to use Noble’s X-STATIC antimicrobial technology in its performance apparel lines. The ...
Israel-based medical device company Brainsway has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to evaluate the efficacy of its Deep TMS device in multi-center smoking cessation study. ...
Tags: Smoking Cessation Study, Health, Medicine
RTI Surgical, provider of orthopedic and other biologic implants, has received a positive feedback from the US Food and Drug Administration (FDA), following its two- day inspection at its Alachua processing facility in Florida. Earlier on ...
Richter-Helm, a full-service biopharmaceutical contract development and manufacturing organization, has announced that the US Food and Drug Administration has approved two Richter-Helm facilities in Hamburg and at Bovenau (to the north of ...
The Pulmonary-Allergy Drugs Advisory Committee (PADAC) of the US Food and Drug Administration (FDA) has recommended the approval of GlaxoSmithKline (GSK) and Theravance's umeclidinium/vilanterol as a treatment for chronic obstructive ...
Tags: Health, Medicine, Investigational Copd Drug
One of the world's top-selling drugs—GlaxoSmithKline PLC's $8-billion-a-year asthma treatment Advair—became more vulnerable to generic competition after the U.S. Food and Drug Administration issued guidance on the regulatory ...
IntelligentMDx (IMDx) has received the US Food and Drug Administration (FDA) approval for its second automated molecular diagnostic test for use on Abbott's fully automated m2000 platform. The automated molecular diagnostic test detects ...
NanoString Technologies, a provider of life science tools for translational research and molecular diagnostic products, has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its Prosigna breast cancer prognostic gene ...