Gedatolisib's NDA for advanced breast cancer treatment has been accepted by the FDA, with a priority review and a PDUFA date set for July 17, 2026. The drug is intended for HR+/HER2–, PIK3CA wild-type ...
In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market ...
New sublingual delivery system designed to enhance bioavailability and speed of onset for major depressive and ...
FDA has requested the HOPE-3 clinical study report (CSR) as part of the BLA review processCompany expects to submit updates ...
PEAK trial first ever study to demonstrate statistical significance over an active comparator in GIST patients, with bezuclastinib plus ...
Zeleciment basivarsen (z-basivarsen) demonstrated sustained functional improvement across multiple clinical measures in the ongoing ACHIEVE clinical trial - ...
The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies ...
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