EMA and the U.S. Food and Drug Administration (FDA) have jointly identified ten principles for good artificial intelligence (AI) practice in the medicines lifecycle. The principles give broad guidance on AI use in evidence generation and monitoring across all phases of a medicine, from early research and clinical trials to manufacturing and safety monitoring.
In 2025, EMA recommended 104 medicines for marketing authorisation. Of these, 38 had a new active substance which had never been authorised in the European Union (EU) before. This includes medicines representing important innovation or contribution to public health, such as the first medicine to treat non-cystic fibrosis bronchiectasis, a first-in-class treatment to delay the onset of stage …
The Indian pharma sector has an increasing number of technological priorities underpinning its digital transformation plans, but those ambitions have only partially been realised.
Novel, naturally-derived polymer capsules developed by a team of Japanese researchers could help to advance more sustainable drug delivery options.
Teva’s Ajovy (fremanezumab-vfrm) has demonstrated potential as the first calcitonin gene-related peptide (CGRP) antagonist treatment option for preventing episodic migraines in paediatric and adult patients.
The U.S. Food and Drug Administration’s (FDA) Office of New Drugs (OND) has released version 4.0 of the OND Custom Medical Queries (OCMQs), which includes terms released in MedDRA v27.0 and earlier.
Jan 14 (Reuters) – The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe and responsible use of artificial intelligence in developing medicines, aiming to speed up innovation while safeguarding patients.
The U.S. Food and Drug Administration published on Monday, January 12, 2025 a draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping drug developers make better use of available data, conduct more efficient clinical trials, and deliver safe and effective treatments to patients sooner.
FDA’s Evaluation Did Not Identify an Increased Risk of Suicidal Ideation or Behavior With the Use of GLP-1 RA Medications
