Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod) 0.92 mg for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Zeposia, an oral medication taken once daily, is the …
Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced on Thursday, that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is being recalled due to product complaints …
AVOID SELF MEDICATION Currently social media groups spreading information regarding the dosage for Corona Virus treatment in the US (Hydroxy Chloroquine + Azithromycin) and stating to have this treatment at home. The World Health Organization recommended that people suffering from COVID-19-like symptoms should avoid self-medicating. As Hydroxychloroquine is prescription only …
On Friday, the World Health Organization (WHO) announced a large global trial, called SOLIDARITY, to find out if any can treat infections with the new coronavirus for the dangerous respiratory disease. The study, which could include many thousands of patients in dozens of countries, has been designed to be as …
Researchers in France have issued a statement detailing how a combination of antimalarial medication and antibiotics could be a vital weapon in the battle against coronavirus. In the statement, which was released Sunday, IHU-Méditerranée Infection in Marseille described: · For all febrile patients who come to consult, to carry out tests for the diagnosis …
The death toll for COVID-19 is on the rise, and so is the total number of cases. In the context of this global pandemic, feeling overwhelmed by all the negative information is a natural response. But researchers are also hard at work trying to understand, treat, and prevent the new …
FDA issued final guidance on Safety Testing of Drug Metabolites on 05 March 2020. The guidance provides recommendations to industry on when and how to identify and characterize drug metabolites should nonclinical toxicity need to be evaluated. The guidance supersedes FDA guidance published in 2016 and aligns FDA guidance with the ICH …
MHRA issued alert to discontinue baricitinib treatment permanently if clinical features of deep vein thrombosis or pulmonary embolism occur. Prescribers are reminded to use caution if using baricitinib in patients with risk factors for deep vein thrombosis or pulmonary embolism in addition to rheumatoid arthritis. Baricitinib (Olumiant) is indicated for …
European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended, as a precautionary measure, that women should stop taking 5mg ulipristal acetate (Esmya and generic medicines) for uterine fibroids while a safety review started this month is ongoing. No new patients should start treatment with these medicines, says the EMA. …