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FDA panel turns down Acadia's Nuplazid for Alzheimer's psych...

Acadia Pharma's attempts to extend the indications of its Nuplazid drug in the US to include Alzheimer's disease-related psychosis have suffered another major setback.

Market Access

Six months after authorization, what do we know about Paxlov...

It has now been over six months since the

Market Access

FDA’s treatment of China-developed drugs spurs demands for m...

China’s emergence as an R&D powerhouse means that the country is quickly adding a number of drug candidates to the global pipeline.

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Genetic engineeering concept with 3d rendering robotic hand editing dna helix

Second unanimous FDA adcomm vote boosts bluebird bio

bluebird bio started last week on tenterhooks, as FDA advisors cast their eyes over data for two gene therapy candidates that are key to its future as a commercially viable concern.

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FDA panel backs bluebird's CALD gene therapy, despite safety...

The FDA may have safety concerns abut bluebird bio's gene therapy for rare, fatal disease cerebral adrenoleukodystrophy (CALD), but its advisors believe its benefits far outweigh the risks.

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