X

Stay Connected

Sign Up for Updates

 
We are creating a place where we can share ideas, provide the perspective of America's biopharmaceutical companies and, most importantly, listen to you.

Ensuring timely reauthorization of PDUFA and BsUFA

By Matthew Norawong  |    May 11, 2022
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...   Read More

ICYMI: New resource catalogs biopharmaceutical industry lessons learned from COVID-19

By Gabby Migliara  |    April 28, 2022
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...   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

The importance of timely PDUFA and BsUFA reauthorization

By Lucy Vereshchagina  |    February 3, 2022
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...   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

World AIDS Day: Remembering those we’ve lost and exploring the continued fight against HIV/AIDS

By Andrew Powaleny  |    December 1, 2021
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...   Read More

Meeting Tomorrow: Looking ahead to PDUFA VII

By Andrew Powaleny  |    September 27, 2021
Tomorrow, PhRMA will participate at the U.S. Food and Drug Administration’s (FDA) public meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA VII).   Read More

PDUFA VII is critical for future biopharmaceutical innovation and for patients

By Richard Moscicki, M.D.  |    August 23, 2021
Today, the U.S. Food and Drug Administration (FDA or Agency) released its performance goals letter for the seventh installment of the Prescription Drug User Fee Act (PDUFA).   Read More

3 things that support robust biopharmaceutical research and development

By Richard Moscicki, M.D.  |    June 29, 2021
Rapid advances in scientific discovery have ushered in a new era of medicine, transforming our ability to treat, and in some cases cure, many of the most challenging diseases, including cancer, rare...   Read More

2020 FDA approvals show innovation despite COVID-19 pandemic challenges

By Andrew Powaleny  |    January 26, 2021
A new report from the U.S. Food and Drug Administration (FDA) notes that the Center for Drug Evaluation and Research (CDER) approved 53 novel drugs last year. These figures are in addition to...   Read More

Search the Catalyst

View Posts by Topic

see all

View Posts by Contributor

View Posts by Date

see all

Subscribe to Email Updates