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Emerg­ing from he­pati­tis B flops, As­sem­bly Bio show­cas­es ear­ly da­ta on next-gen drugs

3 years ago
R&D

Pfiz­er opts in to net Lian­Bio’s rights to RSV can­di­date, putting down $20M up­front

3 years ago
Deals
R&D

FDA lifts hold on stud­ies of blue­bird's sick­le cell gene ther­a­py in ado­les­cents

3 years ago
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Cell/Gene Tx

Madri­gal’s NASH drug wins on piv­otal PhI­II end­points, set­ting stage for ac­cel­er­at­ed ap­proval

3 years ago
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3 years ago
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Cell/Gene Tx
FDA+

FDA sched­ules Covid-19 vac­cine ad­comm to dis­cuss po­ten­tial mod­i­fi­ca­tions and boost­ers

3 years ago
FDA+

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3 years ago
FDA+
Law

US-list­ed Chi­nese biotechs dodge threat of delist­ing

3 years ago
Pharma

What FDA might con­sid­er as de­lay­ing or deny­ing an in­spec­tion: New guid­ance spells out the specifics

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FDA+
Manufacturing

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Discovery

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Startups
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Scoop: Mod­er­na co-founder's re­gen­er­a­tive med­i­cine biotech nabs funds, but los­es Genen­tech

3 years ago
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