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FDA and EMA release collaborative AI framework for drug development
The joint guidance was created to ensure drug developers employ best practices when using AI.
The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
Jan 14 (Reuters) - The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe ...
Speaking at the 2026 J.P. Morgan Healthcare Conference, Hogan Lovells global regulatory partners Elizabeth Jungman and Brian ...
The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process. The regulatory framework has been designed to reduce ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...
CAMBRIDGE, Mass., Jan. 23, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application ...
MetrioPharm’s lead compound, MP1032, has received orphan drug designation (ODD) from the European Medicines Agency (EMA) for treating Duchenne muscular dystrophy (DMD) in children. This follows the ...
ELA026 has demonstrated promising potential as a frontline treatment for patients with sHLH, a hyperinflammatory disease with high mortality and significant unmet medical need Electra has initiated ...
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