regulatory approval

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Immunocore claims first-ever FDA approval for TCR cancer the...

Immunocore has secured a piece of biotech industry history, becoming the first company to get an FDA approval for a cancer therapeutic based on T cell receptor (TCR) technology.

Views & Analysis

Improving Europe’s pharmaceutical regulatory framework

Innovation and access: Improving Europe’s pharmaceutical reg...

EMA “lags behind” other international regulators when it comes to approval timelines, finds EFPIA analysis.

News

Dream result for Idorsia as FDA clears its insomnia drug

Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from Merck & Co and Eisai.

News

Leo puts target on Dupixent in US as FDA clears tralokinumab

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma's rival antibody tralokinumab.

News

Novartis bags elusive US approval for cholesterol drug incli...

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year.

News

Relief for AZ, Amgen as FDA okays severe asthma hope tezepel...

The FDA has approved AstraZeneca and Amgen's severe asthma hope tezepelumab, exonerating the drugmakers' decision to press ahead with a regulatory filing despite a failed phase 3 trial.

Immunocore claims first-ever FDA approval for TCR cancer the...

Innovation and access: Improving Europe’s pharmaceutical reg...

Dream result for Idorsia as FDA clears its insomnia drug

Leo puts target on Dupixent in US as FDA clears tralokinumab

Novartis bags elusive US approval for cholesterol drug incli...

Relief for AZ, Amgen as FDA okays severe asthma hope tezepel...

Getting predictive technologies to patients, with Concr

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

regulatory approval

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