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 ...
Pfizer's rheumatoid arthritis treatment, tofacitinib, has obtained approval in several additional countries globally, including Switzerland, Argentina, Kuwait, UAE and Russia for patients with inadequate response to current therapies. The ...
The UK National Institute for Health and Care Excellence (NICE) has rejected Pfizer’s new chronic myeloid leukaemia (CML) drug, Bosulif (bosutinib). NICE chief executive Sir Andrew Dillon said there is evidence to suggest that ...
Tags: Cancer Drug, Medicine
Purolite, a manufacturer of ion exchange, catalyst, adsorbent and specialty resins, and Codexis, a producer of enzymes, have partnered to develop and commercialize immobilized transaminase enzymes for use in the production of ...
Tags: Transaminase Enzymes, Medicine
Mylan Pharmaceuticals, Mylan's US subsidiary, has launched one of the first generic versions of Abbott's Trilipix Capsule in the US. Known as Fenofibric Acid Delayed-release Capsules, 45mg and 135mg is indicated for patients with mixed ...
The USFDA has cleared Actavis' abbreviated new drug application (ANDA) for Lamotrigine orally disintegrating tablets, 25mg, 50mg, 100mg and 200mg. A generic version of GlaxoSmithKline's Lamictal ODT, the antiepileptic drug is indicated ...
Olde Thompson is recalling 1,075 cases of Earth’s Pride Organics Organic Oregano packed in 2.2oz. glass jar due to possible contamination by Salmonella, according to the US Food and Drug Administration (FDA). The recall affects ...
Specialty pharmaceutical company Actavis has won FDA approval for abbreviated new drug application (ANDA) of generic equivalent to Endo Health Solutions' Opana ER. Oxymorphone Hydrochloride extended-release tablets, which is available in ...
Tags: FDA, ANDA, Generic Opana ER
The US Food and Drug Administration (FDA) has cleared Boehringer Ingelheim's tyrosine kinase inhibitor Gilotrif (afatinib) as a new medication for patients with late stage (metastatic) non-small cell lung cancer (NSCLC). The approval also ...
Tags: FDA, Lung Cancer Therapy, Medicine
India’s Health ministry is planning to organize an inter-ministerial meeting to inspect that the current foreign direct investment (FDI) limit in the pharma industry is not at the cost of the public health goals. The Department of ...
GlaxoSmithKline (GSK) and Theravance have withdrawn license application for the use of inhaled drug fluticasone furoate (FF) and vilanterol (VI), with proposed brand name of Relvar Ellipta, as treatment for chronic obstructive pulmonary ...
Tags: Japan, GSK, Relvar License
Boston Scientific's Guidezilla Guide Extension Catheter has secured 510(k) approval from the US Food and Drug Administration (FDA) and CE Mark, which would enable the company to market the device in the US and European markets. The ...
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. ...