Recovery for Replimune: Accelerated Approval for Cancer Drug Twice Spurned by FDA
Replimune went from an FDA rejection to a resubmission, a positive advisory committee vote, and…
Replimune went from an FDA rejection to a resubmission, a positive advisory committee vote, and finally an accelerated regulatory approval for advanced melanoma — all in less than four months. The FDA nod for Replimune’s oncolytic viral therapy, Tudriqev, positions it as a more convenient alternative to an Iovance Biotherapeutics cell therapy that had been…
Democratic senators are urging CMS to withdraw its Medicaid work requirements rule, arguing it will create administrative burdens and cause eligible beneficiaries to lose coverage. The post Democratic Senators Urge Withdrawal of Interim Final Rule on Medicaid Work Requirements appeared first on MedCity News.
Historically, prevention has focused on protecting teeth from decay and gum disease. However, long-term oral health is also shaped by how the teeth, muscles, and jaw function together over time. The post The Missing Piece of Preventive Dental Care Lies in the Bite appeared first on MedCity News.
Gaps in prevention are not frequently due to a complete lack of information, but instead the fact that organizations don’t have a clear way to see how the pieces fit together until after an incident has occurred. The post Healthcare Workplace Violence Prevention Needs Better Visibility Into Risk Signals appeared first on MedCity News.
This KFF analysis examines physician fee schedules for medication abortion and abortion procedures to see what states that use their own state funds to pay for abortion services are reimbursing for providing abortion services to Medicaid enrollees.
Scheduled for October 29 at Pegasus Park in Dallas, the theme of the INVEST Digital Health conference will be consumers in healthcare from d2c diagnostics to GLP-1 drugs and wearables. Register today! The post INVEST Digital Health Conference Returns with Focus on Consumers appeared first on MedCity News.
Say you live in deep-red Louisiana, a state that has effectively banned abortion. It may be easier for you to get abortion pills now than before the Supreme Court overturned Roe v. Wade. Here’s why — and what it means for future battles over abortion access. And as a federal court mulls a case that…
Your browser does not support the audio element. Can’t see the audio player? Visit kffhealthnews.org to listen. For years, Washington, D.C., has paid for Medicaid — the state-federal health insurance program for low-income people — out of its general budget. But next year, the city is shifting part of that recurring multimillion-dollar cost to a…
By STEVEN ZECOLA Congress will need to amend its faltering Parkinson’s disease legislation if it hopes to achieve meaningful results. Why Change Is Necessary For more than 50 years, the National Institutes of Health (NIH) has pursued Parkinson’s disease (PD) research with limited success. Nearly $5 billion has been spent, yet no approved treatment exists…
The FDA approved Moderna’s flu vaccine mFLUSIVA, a regulatory decision that comes six months after the agency refused to review the mRNA shot and then quickly reversed its position. But a recommendation from a Centers for Disease Control and Prevention advisory committee is key for payer coverage, and that committee has not met all year…