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© 2022 MJH Life Sciences and Formulary Watch. All rights reserved.
© 2022 MJH Life Sciences™ and Formulary Watch. All rights reserved.
September 23, 2022
While some patients with relapsed or refractory multiple myeloma saw a benefit in a confirmatory trial, the main issue concerning the committee members was a high rate of death in the study.
RBX2660 — now with the brand name Rebyota — is a potential first-in-class microbiota-based live biotherapeutic that aims to reduce recurrent C. difficile infection.
September 22, 2022
Several concerns factored into the decision, including a low overall response rate and high rate of adverse events, a dose that was not optimized and a confirmatory trial that will not likely see results until 2026.
This is the first RET Inhibitor for adults with advanced or metastatic solid tumors with a RET gene fusion, regardless of tumor type.
September 21, 2022
Elucirem requires half the gadolinium dose of existing gadolinium-based contrast agents, addressing practitioners’ concerns about gadolinium exposure during MRIs. It will be available in bottle and pre-filled syringe form.
September 20, 2022
Commercial shipments are already under way of Cosette’s gel formulation of tazarotene to treat patients with acne and facial wrinkles.
Veru is seeking an emergency use authorization for sabizabulin, a first-in-class treatment for hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome. The advisory committee meeting is now Nov. 9, 2022.
September 19, 2022
There are currently no FDA-approved therapies that specifically target HER2 in colorectal cancer. The agency has set a target action date of Jan. 19, 2023.
Skysona, with a wholesale acquisition cost of $3 million, is the first FDA approved therapy to slow progression of neurologic dysfunction in boys with this neurodegenerative disease.
Aponvie is the same formulation as Cinvanti, which is an injectable emulsion for prevention of chemotherapy-induced nausea and vomiting.