The EMA initially rejected Rezurock due to uncertainty over its clinical benefit, noting that the pivotal study had no comparator arm and permitted concomitant therapies.
The CHMP issued a negative trend vote but postponed its final decision to December. ・Retail traders were divided, citing ...
The regulator backed the medicine after phase 3 data showed dramatic reductions in HAE attacks and sustained disease control ...
EMA concludes that the primary endpoint and supportive secondary endpoints from prior successful Phase 3 studies conducted in ...
Shares of Anavex Life Sciences (AVXL) slumped 8% in the premarket session on Friday after a European Medicines Agency (EMA) ...
Vikki Velasquez is a researcher and writer who has managed, coordinated, and directed various community and nonprofit organizations. She has conducted in-depth research on social and economic issues ...
Artificial intelligence (AI) will impact every part of the drug life cycle, including production—according to the European Medicines Agency (EMA), which says dialogue is vital for the development of ...
Off-patent medicines provide people with access to high-quality essential treatment options that can be significantly less expensive than branded on-patent medicines. Off-patent therapies — generics ...
CMDB use is critical in multi-cloud environments and is on the rise for 50% of organizations surveyed in a new study based on a research panel of global IT leaders Despite speculation that the rise of ...