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Moderna in talks with FDA over Phase 4 Covid vaccine data

Moderna in talks with FDA over Phase 4 Covid vaccine data

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Moderna said it’s working with US regulators to provide post-marketing data on its Covid-19 vaccines that could restore their use to a wider group after FDA leaders narrowed the label for the products last year.

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Federal appeals court blocks mailing of abortion pill mifepristone

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A federal appeals court has restricted access to one of the most common means of abortion in the U.S. by blocking the mailing of mifepristone prescriptions.

Friday’s unanimous ruling from a three-judge panel of the New Orleans-based 5th U.S. Circuit Court of Appeals is requiring that the abortion pill be distributed only in person and at clinics, overruling regulations set by the federal Food and Drug Administration.

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Bristol Myers’ pivotal year; Should AI be swinging bigger?; and more

Bristol Myers’ pivotal year; Should AI be swinging bigger?; and more

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Welcome back to Endpoints Weekly! The last week of April brought a downpour of news as several pharma companies reported their first-quarter earnings. Max Gelman took a close look at a make-or-break moment for Bristol …​ ​Read More

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Arvinas’ ‘Protac’ breast cancer drug cleared by FDA

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Known as Veppanu, the drug is the first of its kind to get to market. But Arvinas and partner Pfizer are still searching for a new partner to sell it.

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