Market Access News | pharmaphorum

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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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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 psoriasis drug Icotyde heads up the list of new therapies recommended for EU approval at the CHMP's July meeting.

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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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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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AstraZeneca's new breast cancer therapy Etcamah claims landmark frontline approval in the EU, but its prospects in the US are less certain.