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Santhera closes on first approval for DMD drug vamorolone

Swiss biotech Santhera is on the brink of its first regulatory approval for Duchenne muscular dystrophy treatment vamorolone, after getting a positive opinion on the drug

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CHMP backs Almirall’s eczema therapy lebrikizumab

Almirall is within sniffing distance of EU approval for its IL-13 inhibitor lebrikizumab for atopic dermatitis, setting up a challenge to Sanofi and Regeneron’s market-lea

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EMA panel rejects Mirati’s KRAS drug Krazati

Mirati Therapeutics’ hopes of an EU approval for its KRAS inhibitor Krazati in the EU have been thrown into disarray after the EMA’s human medicines committee rejected the

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CHMP backs obesity drug Wegovy for teens

Novo Nordisk’s sought-after obesity drug Wegovy could be approved in the EU shortly for use in adolescents as well as adults.

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Merck will appeal EU rejection of COVID drug Lagevrio

CHMP says evidence for the drug is “not adequate” to show efficacy over standard care.

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EMA reviewing Novartis' Adakveo after phase 3 miss

The EMA's human medicines committee has started a review of Novartis' sickle cell disease (SCD) therapy Adakveo, shortly after the company reported that it failed to show efficacy in a phas

Santhera closes on first approval for DMD drug vamorolone

CHMP backs Almirall’s eczema therapy lebrikizumab

EMA panel rejects Mirati’s KRAS drug Krazati

CHMP backs obesity drug Wegovy for teens

Merck will appeal EU rejection of COVID drug Lagevrio

EMA reviewing Novartis' Adakveo after phase 3 miss

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

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

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