In looking across the past four years of regulatory decisions, we noticed that some of the analyses involving the European Medicines Agency (EMA)'s cycle time used an inappropriate endpoint, which ...

The Space Act, which would apply to local and foreign companies, aims to simplify procedures, protect assets in orbit, level ...

The limited time for discussions with agencies is a barrier, especially during early development, said Shirley Bartido, director of Global Regulatory Affairs Oncology Cell Therapy at Takeda ...

Group of independent publishers alleges the technology is harming their business by diverting web traffic and undermining ...

The European Medicines Agency will review GSK's request to approve its asthma drug Nucala as an additional treatment for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype ...

Here, we introduce the European Platform for Regulatory Science Research, a new initiative jointly led by the EMA and Heads of Medicines Agencies (HMA) in the EU that is set to launch in 2025 ...

Doses were set at 0.5, 5, and 50 mg/kg of body weight per day for two years—levels that align with what European regulatory agencies currently consider safe.

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Uruguay’s MSP has tasked a working group and a proposal has been created by the Faculty of Chemistry at the University of Uruguay.

Airbus, ASML, Lufthansa, Mistral, United Internet and other industry giants are urging in an open letter that the AI ...

Portugal wants European energy regulators' agency ACER to lead an independent investigation into the causes of the huge power outage that brought most of Spain and Portugal to a standstill last ...

European agencies catch up with speedier regulatory pathways for CGTs in the US. ... Mar 21, 2025, 6:01 AM 5 min read. Although the regulatory landscape for advanced therapy medicinal products ...