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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PDUFA and BsUFA reauthorizations are wins for patients

America relies on the U.S. Food & Drug Administration (FDA) to keep pace with the scientific advancements happening every day in labs across the country. That’s why the recently enacted Prescription...
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Timely reauthorization of PDUFA and BsUFA is vital to the FDA’s review of medicines

As we’ve discussed on this blog before, timely reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) is critical to sustaining the U.S. Food and Drug...
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Word of the Month: Biomarkers and surrogate endpoints

What is a biomarker?
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Ensuring timely reauthorization of PDUFA and BsUFA

Today, the House Energy and Commerce Subcommittee on Health will be hosting a markup session on the comprehensive legislative package to reauthorize the human drug user fee programs, including the...
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ICYMI: New resource catalogs biopharmaceutical industry lessons learned from COVID-19

Since the start of the pandemic, America’s biopharmaceutical companies have worked around the clock to research, develop and manufacture treatments and vaccines to fight COVID-19. We’ve made...
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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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The importance of timely PDUFA and BsUFA reauthorization

Today, PhRMA, along with the U.S. Food and Drug Administration (FDA) and other industry trade associations, will be participating in a congressional hearing with the House Committee on Energy and...
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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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World AIDS Day: Remembering those we’ve lost and exploring the continued fight against HIV/AIDS

Today, as we mark World AIDS Day and commemorate those who lost their lives to AIDS-related illnesses, we want to recognize the impressive advancements in HIV/AIDS scientific research and drug...
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