FDA Updates for the Week of Feb. 12, 2024: New Approvals, an Extended Review and Goal Dates Set
February 17th 2024The FDA approves Eohilia for eosinophilic esophagitis and Onivyde for metastatic pancreatic cancer but extends review of gene therapy for rare immune disorder. The agency also set goal dates for three products: full approval for Elevidys, Augtyro for solid tumors with NTRK gene fusions and seladelpar as for rare liver disease.
Read More
New Federal Rule Overhauls Health Insurers' Prior Authorization Processes
February 16th 2024The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need.
Read More
SGLT2 Inhibitors Superior to Other Oral Diabetes Drugs for People with Type 2 Diabetes and NAFLD
February 12th 2024A large retrospective study of patients in South Korea shows that the SGLT2 inhibitors seem to do a better job with bringing about regression of nonalcoholic fatty liver disease.
Read More
FDA Updates for the Week of Feb. 5, 2024: Review Dates and Advisory Committee Meetings Scheduled
February 10th 2024The FDA has set PDUFA dates for several products: Arexvy to prevent RSV in 50 to the 59 population, for acoramidis in heart failure indication, and for an engineered tissue for vascular replacement. The agency has also scheduled an advisory committee meeting for Abecma in supplemental multiple myeloma indication. Additionally, Amneal has resubmitted its application for novel Parkinson’s therapy.
Read More
Community Health Centers Pose as Major Stepping Stone in Post-Incarceration Healthcare
February 10th 2024Providing support to those transitioning into life after incarceration is crucial. This group often faces complex health risks after their release, and maintaining consistent access to substance use disorder treatment plays a significant role in reducing the risk of reincarceration, relapse, and overdose.
Read More
In a retrospective study, researchers from Humana in Louisville, KY, compared clinical outcomes, time on treatment, healthcare resources utilization, and relative costs in patients with MS that were newly initiated on one of the following oral DMTs: dimethyl fumarate, fingolimod, or teriflunomide.
Read More
Studies have shown that the use of oral corticosteroids in patients with UC is associated with higher rates of adverse effects and use of healthcare resources compared with biologics or immunosuppressants. However, there is little research focusing on the economic and clinical burden of chronic corticosteroid use among people living with UC.
Read More