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FDA starts review of Lantheus’ generic Lutathera

Lantheus has filed what it says is the first generic version of Novartis’ big-selling cancer radionuclide therapy Lutathera in the US, used to treat rare neuroendocrine tu

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FDA clears French syphilis drug imports to tackle shortage

Facing a sharp rise in the number of syphilis cases, the FDA has authorised the importation from France of a life-saving drug for the sexually transmitted infection (STI)

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CHMP calls in advisors to assist in Leqembi review

Eisai and Biogen’s marketing application for Alzheimer’s disease therapy Leqembi will face an independent advisory committee convened by the EMA before a decision is made

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Stada, Alvotech get first EU approval for biosimilar Stelara

Johnson & Johnson’s blockbuster immunology drug Stelara is facing its first approved biosimilar in Europe, which is due to launch after the drug loses EU patent protection in July

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AbbVie launches pump-based Parkinson’s drug in EU

AbbVie has launched its Produodopa therapy for Parkinson’s disease onto the market in the EU, becoming the first and only 24-hour levodopa-based subcutaneous infusion ther

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Grifols rocked by fraud allegation from short seller

Shares in Spanish pharma group Grifols have plummeted after UK-based hedge fund Gotham City Research issued a report claiming it has fraudulently manipulated its financial

FDA starts review of Lantheus’ generic Lutathera

FDA clears French syphilis drug imports to tackle shortage

CHMP calls in advisors to assist in Leqembi review

Stada, Alvotech get first EU approval for biosimilar Stelara

AbbVie launches pump-based Parkinson’s drug in EU

Grifols rocked by fraud allegation from short seller

The long-delayed promise of the microbiome, with Sam Possemi...

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