Policy
Jim O’Neill was deputy secretary at the Department of Health and Human Services and also acting director of the CDC after the abrupt ouster of Susan Monarez in August 2025.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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It does not require healthcare workers and first responders to conduct the test using personal protective equipment. Therefore, it should prevent the risk of transmitting the virus.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 21, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 20, 2020.
The U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib) for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
Tukysa came out of Project Orbis, a multinational partnership between the FDA, the Australian Therapeutic Goods Administration, Health Canada, Health Sciences Authority and Swissmedic.
Here’s a look at what’s on the U.S. Food and Drug Administration’s schedule for the next two weeks.
The agency issued a statement saying that it will continue its activities, such as reviewing new drug applications and clinical trial, both COVID-19 and non-COVID-19, applications, “as we do everything possible to maintain continuity of operations in a very dynamic situation.”
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 17, 2020.
As Moderna moves forward with its mRNA vaccine candidate for COVID-19, the U.S. federal government is helping accelerate the potential medication with a $483 million infusion from the Biomedical Advanced Research and Development Authority.
GenSight Biologics, a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, announces the completion of the pre-submission meeting with the European Medicines Agency for the Company’s lead product LUMEVOQ®.