FDA Clears Genentech’s Gazyva for Lupus Nephritis in Adults
Genentech, part of the Roche Group, has announced that the U.S. Food and Drug Administration (FDA) has approved Gazyva® (obinutuzumab) for adults with active...
FDA Approves Celltrion’s EYDENZELT for Retinal Diseases
Celltrion, Inc. said the U.S. Food and Drug Administration (FDA) has approved EYDENZELT® (aflibercept-boav), a biosimilar of EYLEA® (aflibercept), for several retinal conditions. These...
FDA Clears UZEDY Injection for Bipolar I Disorder in Adults
The U.S. Food and Drug Administration (FDA) has approved UZEDY® (risperidone) as a once-monthly, extended-release injectable suspension for adults with bipolar I disorder (BD-I)....
FDA Clears Elecsys pTau181 Alzheimer’s Test by Roche, Lilly
The US Food and Drug Administration (FDA) has approved a new blood test aimed at assessing Alzheimer’s disease and other cognitive impairments, potentially allowing...
EIB, EC to Finance BioNTech’s Kigali mRNA Vaccine Facility
The European Investment Bank (EIB) and the European Commission (EC) are joining forces with BioNTech to push forward a mRNA vaccine facility in Kigali,...
UK Grants Pharma Firms Early Access to Aligned Pathway
Pharmaceutical companies producing qualifying medicines can now benefit from an accelerated approvals pathway, gaining access significantly earlier than initially expected.
The Medicines and Healthcare products...
US FDA Approves Jascayd for Idiopathic Pulmonary Fibrosis
The U.S. Food and Drug Administration (FDA) has approved Jascayd (nerandomilast) tablets to treat idiopathic pulmonary fibrosis (IPF), a rare and serious lung disease....
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The Future of Digital Health
The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution....
Five Best Practices to Deliver Exceptional Multichannel Experiences
A one-size-fits-all customer journey no longer works. In the age of the consumer, the quality of the interaction is paramount. In this paper, we...
The Impact and Use of Social Media in Pharmacovigilance
Social media presents new channels and methods for biopharmaceutical companies to move away from traditional pharmacovigilance (PV) systems and safety reporting methods towards more...