In October 2024, the U.S. Food and Drug Administration (FDA) approved SELARSDI™ for all indications matching the reference product Stelara® (ustekinumab) and has granted a provisional determination of ...

The Department of Justice (DOJ) released a Final Rule restricting certain transfers of Americans’ sensitive personal data to identified countries ...

Allergan Aesthetics, an AbbVie (NYSE: ABBV) company, today announced Allergan Medical Institute (AMI) will open three new ...

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Feb. 05, 2025(Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodi ...

6 The aim of the present study was to evaluate the effectiveness and tolerability of BRV in the postmarketing period to evaluate if the reduction in seizure frequency and adverse events reported in ...

Lack of funding and hesitancy of industry to conduct clinical trials in SSA 2. Lack of access to standard-of-care cancer medications 1. Conduct phase IV postmarketing trials with already established ...

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the ...

The EMA says its Pharmacovigilance Risk Assessment Committee (PRAC), which met last week, will now review all available data on NAION and semaglutide from clinical trials and postmarketing ...

For each vaccine, postmarketing observational studies suggest an increased risk of GBS during the 42 days following vaccination. Arexvy has been approved for the prevention of lower respiratory ...

Objectives: To compare the safety, immunogenicity, and immune persistence of hepatitis A (HA) vaccines between HBs-Ag-positive and -negative participants. Method: 9000 participants were enrolled in ...

Background: A plethora of methods and models of disproportionality analyses for safety surveillance have been developed to date without consensus nor a gold standard, leading to methodological ...