Bioengineered micro-liver platforms developer Hepregen has launched its first application-oriented in vitro kit, called Human HepatoPac, for identification and profiling of drug metabolites. The fully validated DMPK assay kit provides ...
The US Food and Drug Administration (FDA) has issued Breakthrough Therapy Designation for Catalyst Pharmaceutical Partners’ Firdapse (amifampridine phosphate), which is used to treat patients with Lambert-Eaton Myasthenic Syndrome ...
Tags: Therapy Designation, Medicine
Medical device company LDR has received approval from the US Food and Drug Administration (FDA) for commercial sale and distribution of its Mobi-C Cervical Disc (Mobi-C), for two-level indications in the US. The Mobi-C is designed for ...
Tags: Medical device, LDR
Cook Medical has announced that effective October 1, 2013, its Zilver PTX drug-eluting peripheral stent qualifies for new-technology add-on payments under Medicare’s hospital inpatient prospective payment system. In order to qualify ...
Tags: Cook Medical, clinical improvement
HeartWare International has received the U.S. Food and Drug Administration (FDA) approval to enroll supplemental patient cohort for ENDURANCE, a pivotal destination therapy clinical study. HeartWare will enroll up to 286 patients ...
The U.S. Food & Drug Administration (FDA) has categorized Cepheid's Xpert MTB/RIF test as 'moderate complexity' under the Clinical Laboratory Improvement Amendments (CLIA). Xpert MTB/RIF test is designed for the rapid molecular detection ...
Tags: moderate Complexity, Medicine
Bayer HealthCare and Onyx Pharmaceuticals have announced FDA priority review designation for Nexavar (sorafenib) supplemental new drug application for the treatment of radioactive iodine-refractory differentiated thyroid cancer. Nexavar ...
Tags: New Drug Application, FDA
Japanese firms Ono Pharma and Bristol-Myers KK (BMKK) have rolled out the rheumatoid arthritis drug, Orencia Subcutaneous Injection 125mg Syringe 1ml, in Japan. Orencia SC, whose generic name is abatacept, restrains the discharge of ...
Scientists from the University of Strathclyde have invented a unique computer technology that helps in the discovery of smarter drugs to treat major disease, including heart ailments. Dubbed as Shapeshifting Inspired Discovery (SID), the ...
Tags: Faster Drug Discovery, Medicine
InControl Medical has launched InTone, a non-surgical and no-drug solution designed for effective, non-invasive treatment of female urinary incontinence. InTone which is listed as a class II medical device by the US Food and Drug ...
Tags: InControl Medical, launched InTone
The US Food and Drug Administration (FDA) has approved Mirvaso (brimonidine) topical gel, produced by Galderma Laboratories, for the topical treatment of the facial erythema (redness) of Rosacea in adults with 18 years or above. With a 12 ...
Tags: Facial Redness, Treatment
ConAgra Foods, in cooperation with the US Food and Drug Administration (FDA), has announced the recall of a limited number of Kroger’s Break ‘N Bake chocolate chip cookie dough products over packaging issue. The US-based ...
Clinical lab instruments developer Magellan Diagnostics has received the US Food and Drug Administration (FDA) 510(k) approval to market its LeadCare Ultra blood lead testing system in the US. Claimed to be the first plug-and-play ...
Surgical products developer Zimmer Holdings has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Patient Specific Instruments (PSI) Shoulder system. The system enables surgeons to plan the implant ...
Tags: Shoulder System, Surgical products
Medical devices developer Tissue Regeneration Systems has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its new Cranial Bone Void Filler product designed for repair of neurosurgical burr holes. The new ...