CHMP

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Apellis will appeal CHMP’s rejection of pegcetacoplan

Apellis Pharma has said it will seek a re-evaluation of its marketing application for Syfovre for eye disease geographic atrophy (GA) after the EMA’s human medicines committee turned it dow

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First intranasal Epipen alternative backed in EU

An alternative to epinephrine autoinjectors that can be delivered by a nasal spray is close to approval in Europe after being recommended for approval by the EMA’s human medicines committee

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Dupixent nears EU approval for COPD, as FDA delays

Sanofi and Regeneron’s immunology juggernaut Dupixent is on the brink of another big new indication after it was recommended by the EMA’s human medicines committee for chr

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EU rules PTC’s Duchenne drug can stay on the market

Going against the advice of its own advisors, the European Commission has said that PTC Therapeutics’ Translarna therapy for Duchenne muscular dystrophy (DMD) should stay

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J&J gets CHMP nod for Rybrevant in first-line lung cancer

Johnson & Johnson’s Rybrevant is on the brink of EU approval as a treatment for a subset of patients with newly diagnosed EGFR-positive lung cancer, after a recommenda

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CHMP backs Novartis’ Fabhalta as first oral therapy for PNH

The March meeting of the EMA’s human medicines committee (CHMP) saw an approval recommendation for Novartis’ Fabhalta, on track to become the first oral monotherapy for ra

Apellis will appeal CHMP’s rejection of pegcetacoplan

First intranasal Epipen alternative backed in EU

Dupixent nears EU approval for COPD, as FDA delays

EU rules PTC’s Duchenne drug can stay on the market

J&J gets CHMP nod for Rybrevant in first-line lung cancer

CHMP backs Novartis’ Fabhalta as first oral therapy for PNH

Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer

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