FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures
Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels
Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels
The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
The drug is being tested for combined post- and precapillary pulmonary hypertension due to heart failure with preserved ejection fraction
The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study
The study successfully met its primary endpoint, demonstrating similar rates of viral suppression for DOR/ISL compared to Biktarvy at 48 weeks
This is the first and only subcutaneous immune checkpoint inhibitor available in Europe
These initiatives will harness top scientific talent and advanced AI technologies to develop new ways to slow the rise of drug-resistant infections
Over 700 exhibitors from APAC, Europe, the US, and beyond showcased the latest in personal care innovation
The cleared system pairs a flexible nitinol implant with a deployable prong-locking mechanism, delivering rotational and length stability
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