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J&J bids to add smouldering myeloma to Darzalex label

Johnson & Johnson has reported positive phase 3 data with Darzalex in smouldering multiple myeloma (SMM), just before filing applications for the drug in this indication in Europe and t

News

Disc maps out US filing for porphyria drug bitopertin

Disc Medicine has charted a route to market for bitopertin, its drug candidate for rare disease erythropoietic protoporphyria (EPP), after meeting with the FDA.

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Lexicon's type 1 diabetes drug voted down by FDA adcomm

It has been five years since Lexicon Pharma's type 1 diabetes therapy, Zynquista, was rejected by the FDA, and it may struggle to have a better outcome at its second attempt.

News

Eisai, Biogen eye 2025 approval for Leqembi autoinjector

Eisai and Biogen have completed their rolling biologics license application in the US for a subcutaneous formulation of Alzheimer's disease therapy Leqembi previously delayed by the FDA on

Oncology

Juggling CMC trade-offs with personalised cancer vaccines

Personalised cancer vaccines offer significant potential to address an unmet medical need in treatment-resistant disease with fewer side effects and less toxicity compared to standard treat

News

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Astellas pulls geographic atrophy drug filing in the EU

Astellas confirmed today that it will withdraw its EMA filing for avacincaptad pegol as a treatment for eye disorder geographic atrophy (GA), based on feedback from the EU regulator.

J&J bids to add smouldering myeloma to Darzalex label

Disc maps out US filing for porphyria drug bitopertin

Lexicon's type 1 diabetes drug voted down by FDA adcomm

Eisai, Biogen eye 2025 approval for Leqembi autoinjector

Juggling CMC trade-offs with personalised cancer vaccines

Astellas pulls geographic atrophy drug filing in the EU

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How to meet your physicians where they are online

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