Articles related to DEVICE/DRUG APPROVALS

The inavolisib-based regimen more than doubled progression-free survival in PIK3CA-mutated breast cancers, offering a new standard of care for this challenging patient population.

In the BLUE-C trial, Cologuard Plus demonstrated a 93.9% sensitivity for colorectal cancer detection, significantly outperforming the 67.3% sensitivity of FIT.

The Epitomee capsule, a novel ingestible device for weight management, has shown promising results in clinical trials, with 55.5% of users losing at least 5% of their baseline body weight at 24 weeks.

The FDA’s approval of new COVID-19 vaccines targeting the KP.2 strain comes amidst concerns about waning immunity and evolving virus variants.

Erzofri offers a new once-monthly injectable option for treating schizophrenia and schizoaffective disorder, potentially improving medication adherence for some patients.

Lisocabtagene maraleucel offers a new treatment option for patients with CLL who have progressed on both BTK and BCL2 inhibitors, addressing an important unmet need in this patient population.