accelerated approval

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Pharma

BMS is augmenting Zenbexus' efficacy profile in multiple myeloma

BMS has put up the progression-free survival numbers on its recently-approved Zenbexus, more than doubling the score over a control cocktail of DVd.
Fraiser Kansteiner Oct 8, 2026 2:25pm
Karyopharm

Karyopharm reports Xpovio miss, FDA filing in separate cancers

Jul 31, 2026 10:00am
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Regeneron ushers in new era with inaugural gene therapy approval

Apr 23, 2026 3:22pm
FDA

More transparency, evidence needed for accelerated nods: ICER

Apr 17, 2026 11:22am
opening door to brick wall
Favicon Fierce Biotech

Senate hearing takes aim at FDA's rare disease review process

Feb 26, 2026 3:50pm
U-turn pivot about-face

Atara, Pierre Fabre receive 2nd US rejection for Ebvallo

Jan 12, 2026 11:30am