regulatory

News

UK says it has hit target on commercial trial set-up times

The UK has made progress in its efforts to slash set-up times for clinical trials, one of the factors blamed for a decline in industry-backed studies.

News

FDA accelerated approval path needs improvement, says ICER

The FDA's accelerated approval route has delivered important new drugs to patients quicker, but is opaque and plagued by inconsistencies, says ICER.

News

FDA renews criticism of trial sponsors over transparency

The FDA has launched a drive to get clinical trial sponsors to disclose the results of studies – even if they are negative.

News

FDA hands another rejection to Replimune's melanoma therapy

Replimune has had its advanced melanoma treatment RP1 turned down by the FDA for a second time, prompting job losses.

News

Agios' chief medical officer, Sarah Gheuens

Agios mulls early FDA filing for sickle cell therapy

Agios is planning to file its sickle cell disease candidate mitapivat with the FDA under the accelerated pathway within the next few months.

R&D

Test tubes being prepared for flow cytometry

Overcoming 6 data management challenges in flow cytometry

Large-scale flow cytometry delivers critical biological insight by enabling multidimensional analysis of individual cells, making it fundamental to medical research.

UK says it has hit target on commercial trial set-up times

FDA accelerated approval path needs improvement, says ICER

FDA renews criticism of trial sponsors over transparency

FDA hands another rejection to Replimune's melanoma therapy

Agios mulls early FDA filing for sickle cell therapy

Overcoming 6 data management challenges in flow cytometry

Novo sues Lilly over 'misleading' GLP-1 ad campaigning

Discover a new era of healthcare panel engagement: Grounded ...

regulatory

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