Lead Story
FDA proposes to remove oral phenylephrine in selected drugs
The US Food & Drug Administration (FDA) has released an update proposing the removal of oral phenylephrine as the active ingredient in drugs for treating nasal congestion.
Industry news
New cancer drug approved by MHRA
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new drug for non-small cell lung cancer (NSCLC) via a national procedure.
New guidance for wholesalers and manufacturers following Windsor Framework
The Medicines & Healthcare products Regulatory Agency (MHRA) recently published new regulatory guidance for human medicine wholesalers and manufacturers operating within the United Kingdom (UK).
WHO Pandemic Agreement gains signatories
The President of UNITE signs statement in support of the World Health Organization (WHO) Pandemic Agreement
Regulators publish new guidelines for use of AI
The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) publish new guiding principles for the use of large language models (LLMs) in regulatory affairs.
