Articles related to FDA

This drug was first approved in the US in the 1970s for anesthesia and pain relief, and last year, the FDA approved it for patients with major depression that are treatment resistant. If you said ketamine, you’re correct, and because more than 30% of patients are resistant to SSRIs, finding an effective treatment for major depressive disorder is challenging. Could this old drug be the answer?

A neurologist shares his experience receiving the first dose of the vaccine and what he felt during those 15 minutes of observation time. He had some reservations about the safety of the new vaccine, so was he about to become a statistic in the next FDA safety bulletin? Read on to discover the side effect — a feeling he hadn’t experienced in quite some time.

In June 2020, the US Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik, Epizyme), an oral EZH2 inhibitor for the treatment of adult patients with relapsed/refractory follicular lymphoma (FL). Clinical Advances in Hematology & Oncology takes a closer look at this new treatment through a conversation with Dr. Connie Lee Batlevi from MSKCC.

The American Society of Clinical Oncology (ASCO) published a guideline update about the selection of optimal adjuvant chemotherapy regimens and targeted therapy for early breast cancer, namely trastuzumab emtansine. In a second recommendation, the ASCO guideline addressed the use of biosimilar forms of trastuzumab—five of which have been approved by the FDA.

Another win for Merck and Keytruda, as the FDA granted accelerated approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 based on PFS. The FDA also approved a companion diagnostic, PD-L1 IHC 22C3 pharmDx.

The approval of capmatinib and its companion diagnostic is the first of its kind for this specific diagnosis, using next-generation sequencing to perform comprehensive genomic profiling of solid tumors. It now has FDA approval for 21 different agents.