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BioMarin keeps but scales down Roctavian gene therapy ops

BioMarin Pharma has decided not to divest its haemophilia A gene therapy Roctavian, which has struggled to build much traction in the market, but is reining back its ambitions for the busin

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Actinium's radioligand filing plans scuppered by FDA

Shares in Actinium Pharmaceuticals have lost almost two-thirds of their value after the FDA asked for a second clinical trial before it would consider reviewing the company's Iomab-B radiol

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FDA panel backs Zevra's arimoclomol, after earlier rejection

An FDA advisory committee has recommended approval of Zevra Therapeutics' arimoclomol for the ultra-rare disorder Niemann-Pick disease, three years after the regulator rejected the drug.

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GSK bags sought-after Jemperli okay in endometrial cancer

The FDA has cleared GSK's PD-1 inhibitor Jemperli as a treatment for all adult patients with primary advanced or recurrent endometrial cancer, a key part of the company's growth ambitions f

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FDA clears Adaptimmune T-cell therapy for soft tissue cancer

The FDA has given accelerated approval to a groundbreaking T cell-based therapy from Adaptimmune for synovial sarcoma, becoming the first new treatment for the rare soft tissue cancer in mo

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Bayer files first application of menopause drug elinzanetant

Bayer has filed for approval in the US for elinzanetant as a non-hormonal treatment for menopausal symptoms such as hot flushes, with a rival therapy from Astellas in its sights.

BioMarin keeps but scales down Roctavian gene therapy ops

Actinium's radioligand filing plans scuppered by FDA

FDA panel backs Zevra's arimoclomol, after earlier rejection

GSK bags sought-after Jemperli okay in endometrial cancer

FDA clears Adaptimmune T-cell therapy for soft tissue cancer

Bayer files first application of menopause drug elinzanetant

Novo Nordisk's Wegovy pill ad 'misleading', says FDA

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