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Uncategorized1 month agoFDA’s leadership void leaves biotech with renewed ‘uncertainty’
Marty Makary’s resignation leaves the agency with temporary directors in three top positions, and a number of newly instituted policies with an unclear future.
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Uncategorized1 month ago
Abeona pivots to T cells; AstraZeneca’s rare disease drug passes Phase 3
Abeona pivots to T cells; AstraZeneca's rare disease drug passes Phase 3
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Uncategorized1 month ago
Goodbye Galapagos: chameleon company exits the island, rebrands as Lakefront
After a 12-month period that saw the Belgian biotech consider a spinout, swap out CEOs, and enter a three-way acquisition agreement involving Ouro Medicines, Galapagos now...
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Uncategorized1 month ago
Lilly data point to ‘maintenance’ strategies for GLP-1 weight loss
A pair of trial results published in medical journals suggest switching from high-dose injectables to lower doses or pills could help people with obesity keep their...
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Uncategorized1 month ago
UniQure, Replimune shares rise as FDA’s Makary exits, but path forward unchanged
After devastating regulatory setbacks last year, shares of uniQure and Replimune rose on the news that FDA Commissioner Marty Makary is leaving. But analysts don’t expect...
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Uncategorized1 month ago
“It Was Not a Cure”: Musunuru Cautions ASGCT on Baby KJ Promise
BOSTON – When Kiran Musunuru, MD, PhD, walked to the microphone to deliver remarks on behalf of the team that won the American Society of Gene...
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Uncategorized1 month ago
Post-Hoc: Why FDA Commissioner Marty Makary was ousted
Post-Hoc: Why FDA Commissioner Marty Makary was ousted
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Uncategorized1 month agoAssertio accepts new buyout bid; AI biotech Isomorphic banks $2B
Assertio’s latest offer represents a roughly 31% premium over an initial acquisition proposal. Elsewhere, Kyverna is readying a first-of-its-kind approval application and AC Immune is swapping...
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Uncategorized1 month ago
ASGCT 2026: Victoria Gray Roadshow Returns to Boston
BOSTON – The annual American Society of Cell and Gene Therapy (ASGCT) conference got underway in Boston this week with a guest appearance by one of...
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Uncategorized1 month agoNew subpoena suggests DOJ has begun criminal investigation of gender-affirming care
Several hospitals have received federal grand jury subpoenas regarding the provision of gender-affirming care to minors, according to a statement from NYU Langone, a step that...
