Safety

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After phase 3 clean sweep, Roche plans oral BTK filing in MS

Roche is preparing to file for its oral multiple sclerosis drug fenebrutinib after a third phase 3 win, but could liver toxicity be a stumbling block?

R&D

Organoid neurotoxicity testing gains momentum

Organoid-based approaches may become an integral part of neurological safety testing, offering a clearer view of risk.

News

Man with measuring tape around his torso

GLP-1 drugs linked to pancreatitis, gallbladder problems

Users of weight-loss therapies based on GLP-1 agonists have been warned to be aware of a rare complication, pancreatitis, that can be severe.

News

FDA seeks changes to GLP-1, flu shot labels

The FDA has asked manufacturers of GLP-1 drugs used for weight loss to remove warnings of suicidal thinking, but added warnings to flu shots.

News

Andexxa reaches the end of the line in the US

AstraZeneca will voluntarily take its anticoagulant reversal agent Andexxa off the market in the US amid reports of serious clotting side effects.

R&D

Black mouse in a lab on scientist's hand

FDA’s emerging framework to reduce animal testing: Implicati...

Exploring the strategic shift toward reducing reliance on non-human primates (NHPs) and other animal species in R&D.

After phase 3 clean sweep, Roche plans oral BTK filing in MS

Organoid neurotoxicity testing gains momentum

GLP-1 drugs linked to pancreatitis, gallbladder problems

FDA seeks changes to GLP-1, flu shot labels

Andexxa reaches the end of the line in the US

FDA’s emerging framework to reduce animal testing: Implicati...

Remepy's hybrid Parkinson's therapy poised for phase 3

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

Safety

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