FDA maps new regulatory route for ultra-rare diseases
The FDA has sketched out its 'plausible mechanism' regulatory pathway for individualised therapies that treat ultra-rare diseases.
Newsletters and Deep Dive digital magazine
The FDA has sketched out its 'plausible mechanism' regulatory pathway for individualised therapies that treat ultra-rare diseases.
For patients and GPs, accessing NHS services can feel like a "maze of dead ends and detours," according to a new poll.
Amid reports that a shortage of bone cement in the UK is leading to delayed orthopaedic surgeries, Biocomposites has brought forward a product launch.
Texas Attorney General Ken Paxton has filed a lawsuit against Sanofi, claiming the company bribed doctors to prescribe its medicines.
The FDA plans to adopt a new policy that will do away with the default requirement to base regulatory filings for new medicines on two pivotal trials.
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