Tryvio TM (aprocitentan) is now available for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure (BP) in adult patients who are not adequately ...
PreHevbrio was approved for the prevention of infection caused by all subtypes of hepatitis B virus in adults aged 18 years and older.
Supplementation with cholecalciferol during pregnancy linked to increased bone mineral content, bone mineral density, lean mass in offspring ...
A Prescription Drug User Fee Act date of April 2, 2025 has been assigned to the resubmitted application. The Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug ...
The Company is seeking approval of tirzepatide for the treatment of HFpEF and obesity and has submitted data to the FDA. Detailed results were announced from a phase 3 clinical trial evaluating the ...
Source: Getty Images “The potential adverse impact of chemotherapy exposure during pregnancy is likely mediated through ...
Researchers analyzed whole-genome sequencing data from 76,805 patients to identify variants in 4 genes that are associated ...
The Food and Drug Administration (FDA) has expanded the approval of Nerivio ® (Theranica) to include the acute and/or ...
According to the Company, the product is expected to be available in the coming weeks through Biologics by McKesson and Limited Specialty Distribution. The Food and Drug Administration (FDA) has ...
The new PDUFA target date is April 18, 2025. The Food and Drug Administration (FDA) has accepted for review the resubmitted supplemental Biologics License Application (sBLA) for Dupixent ...
One year after reports of supply chain issues, 49% of reports in the US and 34% of reports in Canada were associated with ...
The sNDA was submitted to support full approval of OCA for this indication based on data from the COBALT trial, as well as real-world evidence.