Articles related to DEVICE/DRUG APPROVALS

A look into the FDA’s rigorous 2023 drug approval process, including a record number of new medicines and notable rejections. Understanding these trends is essential for anticipating future treatment landscapes.

The bispecific antibody targets both CD20 and CD3 proteins and has demonstrated the capacity of activated immune cells to eliminate lymphoma cells, achieving deep and potentially curable remissions.

Leqembi, a newly FDA-approved drug, has shown promising results in clinical trials, resulting in a 28% slower decline in Alzheimer’s patients compared to placebo. This equates to an additional four to five months of retained function.

The FDA’s recent approval of toripalimab, based on the JUPITER-02 and POLARIS-02 clinical trials, marks a significant milestone in the treatment of nasopharyngeal carcinoma. With a median progression-free survival of 11.7 months, toripalimab has shown promising results in improving patient outcomes.

The approval of empagliflozin opens up a new avenue in CKD treatment. With its proven efficacy in reducing the risk of disease progression by 28%, it offers a promising alternative for healthcare professionals dealing with this prevalent condition.

With the approval of Vabysmo, it’s a new era in the treatment of macular edema following RVO. This therapy has demonstrated comparable vision gains to aflibercept in clinical trials, offering a promising alternative for your patients.