EMA had released its first safety update on a COVID-19 vaccine — Comirnaty. It concludes that safety data collected on Comirnaty use in vaccination campaigns is consistent with the known safety profile of the vaccine, and no new side effects were identified. Summary points: The latest safety data for this vaccine are …
Indian drug firms like Lupin, Marksans Pharma, Aurobindo Pharma and Alembic Pharmaceuticals are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Lupin and Marksans Pharma are recalling diabetes drug, Aurobindo and Alembic are recalling psychiatric medication in …
AstraZeneca Pharma India has received the Marketing Authorization for Dapagliflozin (Forxiga), for the treatment of patients with heart failure with reduced ejection fraction (HFrEF). This is the first in class SGLT-2 inhibitor drug approved for the treatment of HFrEF. Reportedly, it is the first drug proven to significantly reduce the …
GSK Consumer Healthcare is voluntarily recalling to the retail level two lots of Children’s Robitussin® Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. During the review of the packaging documents for these products, GSK discovered …
The FDA has approved a new use for AstraZeneca’s Farxiga (dapagliflozin) to reduce risk of cardiovascular death and hospitalisation with heart failure, in adults with reduced ejection fraction heart failure, with or without type 2 diabetes. AZ is building a metabolic and cardiovascular franchise around Farxiga, which was first approved in type 2 diabetes and was added to the company’s portfolio …
Preterm babies are at high risk of abnormal blood vessel growth in the retina, the light-sensitive tissue in the back of the eye. These abnormal blood vessels are fragile and prone to leaking. If left untreated, vessel growth can lead to scarring and retinal detachment, the main cause of ROP-related …
The U.S. Food and Drug Administration has issued a warning letter to a seller that markets fraudulent and dangerous chlorine dioxide products known as “Miracle Mineral Solution” for prevention and treatment of “Novel Coronavirus Disease 2019” (COVID-19). The FDA has previously warned consumers not to purchase or drink chlorine dioxide products sold online as …
Jakavi (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. Jakavi is approved in 101 countries for the different indications including treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea and for the treatment of disease-related splenomegaly or …
Drug labels for doxycycline, clindamycin and caffeine citrate now include better information for healthcare providers on recommended usage and dosage in pediatric populations. The data that informed these label changes came from research funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National …
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 …
