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Teos announced in May it was winding down operations, following disappointing Phase II study results for its anti-TIGIT antibody.
The FDA had made the request Friday, which Sarepta initially rebuffed, following the death of a third patient treated with one of the firm's gene therapies.
Researchers explored changes in survival outcomes and financial strain for NSCLC patients during a time when new targeted therapies were hitting the market.
The study will compare neladalkib to Genentech's ALK inhibitor Alecensa in patients who've had no prior systemic treatment.
The FDA requested Sarepta voluntarily stop distributing Elevidys after the death of a third patient who received one of the firm's gene therapies.
Company touted Kisqali's "replacement power" as another blockbuster faces generic competition and expressed optimism about ...
In a final draft guidance, the committee recommended the treatment for HR-positive HER2-negative early breast cancer patients, regardless of lymph node involvement.
The participating regions are home to 84 percent of sickle cell Medicaid patients who could gain access to gene therapies under outcomes-based agreements.
For $1.8 million upfront and additional contingent and milestone payments, I-Mab gains full rights to givastomig's parental antibody.
A 51-year-old man with limb-girdle muscular dystrophy died after receiving Sarepta's experimental gene therapy and experiencing acute liver failure.
The company will pause several gene therapy development programs, for which it intends to seek partners and other strategic alternatives.
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