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Setting the record straight on accelerated approval

By Andrew Powaleny  |    May 22, 2023
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...   Read More

A guide to MedPAC’s Part B vote today

By Nicole Longo  |    April 13, 2023
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...   Read More

MedPAC proposal threatens access to medicines in Part B

By Nicole Longo  |    April 6, 2023
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...   Read More

Novel medicines approved in 2022 offer increased treatment options for patients

By Andrew Powaleny  |    January 23, 2023
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...   Read More

Three things to know about the accelerated approval pathway

By Lucy Vereshchagina  |    December 12, 2022
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...   Read More

The accelerated approval pathway: Helping patients with serious or life-threatening diseases

By Andrew Powaleny  |    March 17, 2022
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...   Read More

ICYMI: New approvals by the FDA in 2021 offer greater treatment options for patients

By Richard Moscicki, M.D.  |    January 26, 2022
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)....   Read More

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