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FDA advisors vote no to Capricor's DMD therapy
FDA advisors voted that Capricor has not shown efficacy for deramiocel in Duchenne muscular dystrophy, due to altered endpoints in its main trial.
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EU first to clear AbbVie's Rinvoq for alopecia areata
AbbVie's fast-growing JAK inhibitor Rinvoq has been cleared for alopecia areata in the EU, its first market for the hair loss disorder.
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J&J's oral IL-23 drug backed for psoriasis in EU
J&J's oral psoriasis drug Icotyde heads up the list of new therapies recommended for EU approval at the CHMP's July meeting.
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Outlook finally claims FDA approval for AMD drug
After three knockbacks by the FDA, Outlook has finally pushed its therapy for age-related macular degeneration over the finish line in the US.
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Re-rostered FDA committee backs peptide compounding
Against the advice of FDA staff scientists, an advisory committee has narrowly voted in support of looser restrictions on compounded peptides.
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