Mylan Pharmaceuticals and Orion have entered into a settlement and license agreement, which dismisses the parties pending litigation related to Mylan's filing of an Abbreviated New Drug Application (ANDA) with the US FDA for the generic ...
Tags: Mylan, Orion, Generic Version
American Regent, a subsidiary of a Daiichi Sankyo Group Company named Luitpold Pharmaceuticals, has won USFDA approval for Injectafer (ferric carboxymaltose injection) for the treatment of iron deficiency anemia (IDA). A parenteral iron ...
Tags: Iron Deficiency Anemia, Medicine
Techne has completed the acquisition of Bionostics Holdings and its operating subsidiary Bionostics for approximately $104m in cash. Bionostics is a developer and manufacturer of control solutions that verify the correct operation of ...
Tags: Techne, Bionostics Acquisition
Hologic, a developer of medical imaging systems and surgical products, has received approval for its Aptima HPV assay for use on its fully-automated Panther system from the US Food and Drug Administration (FDA). The assay is a nucleic ...
Tags: Aptima HPV, Medicine
AbbVie's Humira (adalimumab), a rheumatoid arthritis drug, has been rejected by the US FDA advisors for use in the treatment of a spinal inflammatory disease, non-radiographic axial spondyloarthritis. The FDA's Arthritis Advisory ...
Biopharmaceutical development company Chelsea Therapeutics has announced the US FDA acceptance of Northera (droxidopa) new drug application (NDA) resubmission to treat symptomatic neurogenic orthostatic hypotension (NOH). The company is ...
Clinical-stage pharmaceutical company Adynxx has obtained the US Food and Drug Administration (FDA) fast track designation for its AYX1 injection, which is used for prevention of chronic pain. In a five-cohort, dose-escalating study ...
The US FDA has approved Janssen Biotech's Simponi ARIA (golimumab) for infusion to treat moderately to severely active rheumatoid arthritis (RA). Simponi ARIA is the only fully-human anti-tumor necrosis factor (TNF)-alpha infusible ...
SynGen has received 510(k) approval from the US Food and Drug Administration (FDA) to market its SynGenX-1000 System, CryoPRO-2 Cryopreservation/Storage Bag Set, SynGen DataTrak software products to process cord blood. Previously, the ...
Tags: Cord Blood Processing, Syngen
The US Food and Drug Administration (FDA) has issued a Class I recall of Medtronic’s MiniMed Paradigm Insulin Infusion Sets. The Paradigm infusion sets are meant for use with Paradigm insulin infusion pumps. These infusion sets are ...
Luminex has received approvals from the US Food and Drug Administration (FDA) and EU authorities for the new version of xTAG CYP2D6 (Cytochrome P450 2D6) Kit. An IVD assay, the xTAG CYP2D6 Kit analyses a patient's CYP2D6 genotype from ...
The US Food and Drug Administration (FDA) has permitted the sale of Verify Cronos Self Contained Biological Indicator (SCBI), a new quicker testing method to check the effectiveness of steam sterilization of reusable medical devices. ...
CryoLife has received premarket approval from the US Food and Drug Administration (FDA) for its new Sologrip, a minimally invasive laser fiber-optic delivery system. The Sologrip delivery system is a single-use, disposable handset ...
The US FDA has accepted to review Bristol-Myers Squibb Company and Pfizer's Eliquis (apixaban) supplemental new drug application for prophylaxis of deep vein thrombosis (DVT) subsequent to hip or knee replacement surgery. The application ...
Tags: Drug Application, Medicine
Sectra has registered Sectra DoseTrack, a new class 1 software medical device, with the US Food and Drug Administration (FDA). Sectra DoseTrack is a web-based solution to monitor patient radiation doses and check whether they are kept as ...
Tags: Sectra, Sectra DoseTrack