The anxiolytic etifoxine can continue to be given to patients with anxiety disorders provided they have not previously experienced severe dermatological or hepatic side-effects after taking the drug, the European Medicines Agency has advised.
EU OKs Continued Use Of Etifoxine For Anxiety Despite Toxicity Concerns
The European Medicines Agency has also recommended that EU member states go ahead and approve Tiofarma’s midazolam nasal spray Nasolam for convulsive seizures, while a review of a lidocaine/prilocaine product from French firm International Drug Development has been stopped after the applicant withdrew its decentralized marketing authorization application.
More from Europe
• By
Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
• By
Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.
• By
Sponsors of three drugs that are in the final stages of the EU regulatory review cycle are due to make the case for marketing approval before the European Medicines Agency.
• By
Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
More from Geography
• By
The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.
• By
A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.
• By
Democrats opposed the nomination because they believe Mehmet Oz will not defend Medicaid from spending cuts. His pledge to continue lowering drug costs in Medicare and Medicaid did not offset the concerns.