WHO is alerting health-care professionals and regulatory authorities to the risk of non-arteritic anterior ischemic optic neuropathy (NAION) associated with the use of semaglutide medicines—Ozempic, ...

Omeros Corporation (Nasdaq: OMER) today announced the recent submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for narsoplimab for the treatment of ...

Objectives To assess the use, and evaluate the usefulness, of non-interventional studies and routinely collected healthcare data in postmarketing assessments conducted by the European Medicines Agency ...

First-in-human trial of AX-0810 will evaluate safety, tolerability, pharmacokinetics, and target engagement in healthy volunteers with initial data expected in Q4 2025; Marks the ...

Regulators and manufacturers advance biosimilars for aflibercept, omalizumab, and dupilumab, enhancing access to treatment in ...

A new gene therapy delivery device could let hospital pharmacies make personalized nanomedicines to order. This democratized approach to precision medicine, as published in Frontiers in Science, could ...

A new gene therapy delivery device could let hospital pharmacies make personalized nanomedicines to order. This democratized ...

Canalevia® (crofelemer delayed-release tablets), under the name Canalevia-CA1, is conditionally approved by the FDA for ...

The efficacy data of aficamten in obstructive HCM patients with mild symptoms from SEQUOIA-HCM were simultaneously published ...

Rezdiffra is already approved and available in the US for adults with noncirrhotic MASH who have moderate to advanced liver ...

Novo Nordisk NVO announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has ...