regulatory

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FDA delays decision on Sanofi's subcutaneous Sarclisa

The FDA has extended its review of a new version of Sanofi's multiple myeloma Sarclisa that could help narrow the gap with arch-rival Darzalex.

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FDA kicks off review of Roche's Gazyva for wider lupus use

Roche could be just months away from an FDA approval of Gazyva as the first anti-CD20 therapy for systemic lupus erythematosus.

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US President Donald Trump with the signed Order

Trump signs order to hasten psychedelic medicine access

Donald Trump has signed an executive order directing the FDA to reduce regulatory hurdles that stand in the way of bringing psychedelics to patients.

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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.

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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.

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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.

FDA delays decision on Sanofi's subcutaneous Sarclisa

FDA kicks off review of Roche's Gazyva for wider lupus use

Trump signs order to hasten psychedelic medicine access

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

Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer

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

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