US-based ingredients supplier Omya is voluntarily recalling certain lots of food grade ground limestone products processed at its facility in Arizona due to possible Salmonella contamination. The products being recalled include Omya-Cal ...
Tags: Omya, recall, food grade ground limestone product, Salmonella, food safety
Merit Medical Systems has gained US marketing rights for its ONE Snare Endovascular Snare system, following the Food and Drug Administration's (FDA) approval. Single-loop snare system is designed to provide both accuracy and reliability ...
Tags: Merit Medical Systems, ONE Snare Endovascular Snare system, FDA
Molecular diagnostics company Exact Sciences has submitted to the US Food and Drug Administration(FDA)the first module of the premarket approval(PMA)application for its stool DNA colorectal cancer screening test. The first modular ...
Tags: molecular diagnostics, Exact Sciences, PMA application
Medical device company Nexstim in Finland,has obtained CE mark approval for its non-invasive Navigated Brain therapy(NBT)system. The system featuring MRI-based navigation allows users to visualize the electric field inside the patient's ...
Tags: medical device, Nexstim, NBT system, brain
The US Food and Drug Administration(FDA)has granted 510(k)approval to Blue Belt Technologies'orthopedic surgical system for use in Unicondylar Knee Replacement(UKR)procedures. Using the company's patented technology,the CE-marked NavioPFS ...
Tags: Blue Belt Technologies'orthopedic surgical system, UKR, NavioPFS system
Janssen's Zytiga indicated for metastatic castration-resistant prostate cancer(mCRPC),has won FDA approval for use in patients who have not received chemotherapy. The oral,once-daily medication was previously used in combination with ...
Germany-based Bayer HealthCare's Consumer Care division has begun a voluntary recall of BRONKAID Caplets Dual Action Formula in consultation with the US Food and Drug Administration (FDA), over labeling issue. Bayer has identified that ...
Tags: health care, recall, FDA, labeling issue, expiration date
Aequus BioPharma,a subsidiary of Cell Therapeutics,has named Ronald Berenson as the company's new president and CEO. Prior to joining the company,Berenson served as president and CEO at HemaQuest Pharmaceuticals and as ...
Tags: Aequus BioPharma, Cell Therapeutics, CEO, Ronald Berenson
Horizon Pharma has commercially launched Rayos (prednisone) delayed release tablets in the US. Rayos is used to treat rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma ...
Tags: Horizon Pharma, Rayos, rheumatoid arthritis
Epigenomics has reported positive results from a clinical study, which showed that its blood-based colorectal cancer (CRC) detection test is non-inferior in sensitivity when compared to fecal immunochemical testing (FIT). Using patients ...
Tags: Epigenomics, blood-based colorectal cancer, non-inferior in sensitivity
IRIDEX has obtained FDA's 510(k) approval and CE mark for its non-invasive laser delivery system, designed for treating serious retinal diseases. Using MicroPulse technology, the new TxCell Scanning laser delivery system saves time in a ...
Tags: IRIDEX, non-invasive, laser delivery system, CE mark approvals
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for generic Atacand HCT tablets to treat hypertension. Candesartan Cilexetil and Hydrochlorothiazide Tablets in 16/12.5mg, 32/12.5mg and 32/25mg ...
Tags: US FDA, hypertension medication, ANDA, hypertension
AstraZeneca and US Food and Drug Administration (FDA) have agreed to update label for Faslodex (fulvestrant) injection. The updated prescribing information for Faslodex US contains results and a Kaplan-Meier plot of the final overall ...
Tags: AstraZeneca, Faslodex injection label, US, FDA
Janssen Biotech and Janssen Biologics are seeking approval for Stelara in the US and Europe for the treatment of active psoriatic arthritis. A supplemental biologics license application (sBLA) was submitted to the FDA and a Type II ...
Biopharmaceutical company AstraZeneca has announced agreement with the US Food and Drug Administration (FDA) with regard to FASLODEX (fulvestrant) Injection label changes. The labeling update includes results and a Kaplan-Meier plot of ...
Tags: FASLODEX Injection label, AstraZeneca, prescription medicines