Setting the record straight on accelerated approval

As we’ve discussed on this blog before, the U.S. Food and Drug Administration’s (FDA) accelerated approval program has served as a critical lifeline for patients with serious and life-threatening...
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A guide to MedPAC’s Part B vote today

Today, the Medicare Payment Advisory Commission (MedPAC), an independent congressional agency that advises Congress on issues related to the Medicare program, will vote on draft recommendations...
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MedPAC proposal threatens access to medicines in Part B

Next week, the Medicare Payment Advisory Commission (MedPAC) will vote on a number of policy proposals for changing Medicare Part B. One of the proposals would recommend that Congress adjust the...
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Novel medicines approved in 2022 offer increased treatment options for patients

2022 marked another year of significant progress by biopharmaceutical research companies conducting lifesaving research and development for innovative medicines with a total of 45 new medicine...
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Three things to know about the accelerated approval pathway

If you or a loved one were to receive a diagnosis of a serious or life-threatening disease, you would likely want access to a U.S. Food and Drug Administration (FDA) approved safe and effective...
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Word of the Month: Biomarkers and surrogate endpoints

What is a biomarker?
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The accelerated approval pathway: Helping patients with serious or life-threatening diseases

Today, the House Energy & Commerce Committee’s Subcommittee on Health will meet to discuss policy proposals to “encourage innovation and improve oversight” regarding medical innovation. This hearing...
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ICYMI: New approvals by the FDA in 2021 offer greater treatment options for patients

The U.S. Food and Drug Administration (FDA) approved a total of 60 new drugs in 2021. A new report from the FDA catalogs 50 new approvals by the Center for Drug Evaluation and Research (CDER)....
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