Articles related to FDA

The FOENIX*-CCA2 trial, a global phase 2, open-label trial examining 103 patients with unresectable, locally progressed, or metastatic iCCA harboring FGFR2 gene rearrangements including fusions, was the basis for the approval of futibatinib (Lytgobi, Taiho Oncology). Patients in this trial received 20 mg of futibatinib orally once daily until disease progression or intolerable toxicity; the primary end goal was achieved with a 42% objective response rate as determined by an impartial central evaluation. With 72% of responses lasting at least six months, the median response time was 9.7 months.

The MajesTEC-1 trial, a phase 1/2 open-label research that revealed effectiveness data from 110 patients with relapsed or refractory multiple myeloma, provided evidence from strong response rates that served as the foundation for the approval. The accelerated approval of a bispecific antibody for the incurable blood malignancy is a first of its kind in the US. Proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody must have been used in prior therapy.

Part 1—Pain Management Fundamentals Following completion of this activity (1.0 AMA PRA Category 1 Credit™, 1.0 AANP credit, 1.0 ACPE credit, 1.0 ANCC credit), the participant should be able to: Explain the importance of comprehensive pain education Outline the fundamental concepts of pain management, such as pain definitions and pain mechanisms. Examine patients who are in pain, including identifying risk factors for substance abuse and addiction. Discuss the various pain-management approaches, including nonpharmacologic and pharmacologic (non-opioid and opioid analgesic) therapies.

The IV-equivalent formulation is indicated for the treatment of congestion due to fluid overload in people with NYHA class II/III chronic heart failure and may offer a substantial change in the management of the condition.

Study: This meta-analysis includes 232 randomized, double-blind, placebo-controlled trials of drug monotherapy for major depressive disorder submitted to the FDA between 1979 and 2016, and comprises nearly 75,000 adult and child participants. Conclusion: Patients with depression are likely to improve substantially from acute treatment of their depression with drug or placebo. Although the mean effect of antidepressants is only a small improvement over placebo, the effect of active drug seems to increase the probability that any patient will benefit substantially from treatment by about 15%.

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).