regulatory approval

News

EU clears AZ, Ionis' Wainzua for ATTR polyneuropathy

AstraZeneca and Ionis add an EU green light to earlier approvals in the US and UK for ATTR polyneuropathy drug Wainzua, a potential blockbuster.

News

Neurotech's cell therapy gets FDA nod for eye disorder MacTe...

Neurotech Pharma's cell therapy Encelto has become the first FDA-approved therapy for idiopathic macular telangiectasia type 2.

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Roche ends the 30-year US hiatus in new stroke drugs

Genentech has won FDA approval for its clot-buster TNKase as a treatment for acute ischaemic stroke, after almost abandoning the project in 2023.

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FDA clears first therapy for rare disease CTX from Mirum

Mirum Pharma's Ctexli has become the first FDA-approved therapy for ultra-rare disease cerebrotendinous xanthomatosis (CTX).

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Shionogi gets approval in Japan for ADHD digital therapeutic

Shionogi will market the EndeavorRide app, originally licensed from Akili, in Japan following its approval by the MHLW regulator.

News

First biosimilar fast-acting insulin reaches US market

Sanofi has claimed FDA approval for the first biosimilar of Novo Nordisk's rapid-acting insulin analogue Novolog.

EU clears AZ, Ionis' Wainzua for ATTR polyneuropathy

Neurotech's cell therapy gets FDA nod for eye disorder MacTe...

Roche ends the 30-year US hiatus in new stroke drugs

FDA clears first therapy for rare disease CTX from Mirum

Shionogi gets approval in Japan for ADHD digital therapeutic

First biosimilar fast-acting insulin reaches US market

ACC25: Ozempic shows its value in PAD

Health Trends 2025: Reimagining What's Possible

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regulatory approval

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