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FDA reviewer pokes holes in Geron’s MDS drug data

Geron could have a tougher time than it anticipated at tomorrow’s FDA advisory committee meeting for myelodysplastic syndromes (MDS) drug candidate imetelstat.

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Justin Klee and Joshua Cohen, co-CEOs of Amylyx Pharma

Amylyx plummets as confirmatory trial of ALS drug fails

Shares in Amylyx have cratered after the company reported a confirmatory trial of its amyotrophic lateral sclerosis (ALS) therapy Relyvrio missed all its objectives, putti

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Lilly’s Alzheimer’s drug delayed as FDA seeks adcomm

The FDA has said it will seek the advice of independent advisors before it concludes its review of Eli Lilly’s amyloid-targeting Alzheimer’s disease therapy donanemab, del

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MindMed gets FDA breakthrough tag for LSD in anxiety

In another inflection point for the psychedelic medicines category, Mind Medicine (MindMed) has claimed breakthrough status from the FDA for its LSD-based candidate MM120

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EMA starts twin reviews of AZ, Daiichi’s Dato-DXd

The clock has started ticking in the EU on two marketing applications for AstraZeneca and Daiichi Sankyo’s TROP2-targeting antibody-drug conjugate datopotamab deruxtecan i

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4SC files maintenance CTCL therapy Kinselby in EU

German biotech 4SC has filed its oral HDAC inhibitor Kinselby with the EMA, hoping to provide a much-needed new therapy for patients with the rare cancer cutaneous T-Cell

FDA reviewer pokes holes in Geron’s MDS drug data

Amylyx plummets as confirmatory trial of ALS drug fails

Lilly’s Alzheimer’s drug delayed as FDA seeks adcomm

MindMed gets FDA breakthrough tag for LSD in anxiety

EMA starts twin reviews of AZ, Daiichi’s Dato-DXd

4SC files maintenance CTCL therapy Kinselby in EU

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