In October, the EMA announced that it was looking to improve the efficiency of its approval process for new medicines in the European Union (EU). The stated aim for the agency was to better manage ...

Mía had dystrophic epidermolysis bullosa, better known as butterfly skin due to the extreme fragility of this tissue in ...

The European Medicines Agency (EMA) has issued a warning about the dangers ... but does not mention therapy-specific ...

A false claim is circulating online that the European Medicines Agency (EMA) has acknowledged that mRNA vaccines have not been formally approved and that millions have therefore been vaccinated ...

Patients should have faster access to newly developed drugs and ... drugs already approved by the European Medicines Agency, even though the Government’s guidelines say the process should ...

Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.

ImmunityBio, the Culver City immunotherapy developer founded by Patrick Soon-Shiong, seeks approval ... drug to Europe. On Jan. 27, ImmunityBio announced that the European Medicines Agency ...

The FDA has granted approval to an act of compassionate use treatment with the anti-cancer drug Namodenoson for a patient ...

The European orphan drug market is growing and is already comparable in size and scope to the US market. The European Union (EU) counts 36 million rare disease patients, and the European market is ...

Exploring Regulatory Affairs, the discipline dedicated to ensuring that new drugs and biologics are safe, effective, and ...

The TxGemma models are – as the name suggests – an offshoot of Google's Gemma family of open-source, generative AI (GenAI) ...