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.

The privately funded basket trial makes good on its aim to enroll underrepresented groups amid a DEI-hostile federal funding ...

In a final draft guidance, the committee recommended the treatment for HR-positive HER2-negative early breast cancer patients, regardless of lymph node involvement.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 biotech will add a pivotal Phase III cohort to its ongoing Phase I/II trial evaluating ATSN-201 in X-linked retinoschisis ...

Company touted Kisqali's "replacement power" as another blockbuster faces generic competition and expressed optimism about ...

A team at the Peter Mac is planning for first-in-human trials in five years, hoping this new therapy will eschew the ...

NEW YORK – Sarepta Therapeutics on Wednesday said it would pivot to focus its rare genetic disease pipeline on siRNA drugs as part of a strategic restructuring plan to prioritize "high-value, high ...

The Whitrod family launched Genetic Cures for Kids in the hopes of finding a treatment for their daughter with hereditary ...

For $1.8 million upfront and additional contingent and milestone payments, I-Mab gains full rights to givastomig's parental antibody.

Data from a Phase I trial of Avmapki Fakzynja also supports the regimen's tolerability and suggests its potential activity in ...