Articles related to DEVICE/DRUG APPROVALS

FDA approved new indications for these drugs in July, include a Janus kinase inhibitor and a phosphodiesterase-4 inhibitor for use in dermatology, a carbonic anhydrase inhibitor for partial-onset seizures, and an expanded indication for the TKI crizotinib.

Kar-XT adds trospium to xanomeline to substantially improve the second agent’s tolerability, enabling its use to reduce both positive and negative symptoms in schizophrenia. Allopregnanolone, an oral version of brexanolone, is being investigated in MDD. The dextromethorphan and bupropion combo, AXS-05, seeks to offer a new antidepressant option and hydroxynorketamine promises MDD treatment without ketamine’s dissociative effects and abuse potential.

The Emergency Use Authorization (EUA) for Paxlovid has been revised to reflect the new prescribing authority given to state-licensed pharmacists. Under this revision, patients must now show health records within the last year, which needs to include bloodwork, as well as a list of their current medications, including any over-the-counter (OTC).

There are no approved medications for the core symptoms of autism spectrum disorder (ASD), socialization and communication difficulties. Did balovaptan, an oral selective vasopressin 1a receptor antagonist, help us get closer to an approved drug?

Copiktra (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), is indicated for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least 2 prior therapies. Based on the results of a clinical trial evaluating the long-term effects of the drug, the FDA recommends that health care providers evaluate the risks and benefits of continuing Copiktra vs. prescribing an alternative therapy.

A fact-filled video program all about ALZ-801 (valiltramiprosate), an oral medication with a novel mode of action that aims to slow or stop Alzheimer’s disease altogether.