News

100 days into the job, FDA head talks to CNN about agency goals— and Coke’s switch to sugar
Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...
PharmExec2d
Replimune CRL Fallout: How Biopharma Leaders Should Manage a New Layer of FDA Uncertainty
A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...
BioSpace4d
From Expertise to Empty Chairs: The FDA’s Self-Inflicted Crisis
While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience ...
FDA names former pharmaceutical company executive to oversee US drug program
The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency’s drug program, the ...
BioSpace4d
FDA Opens Pilot Run of Commissioner Voucher Program
The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...
Fierce Pharma13d
Ultragenyx takes another hit as FDA snubs AAV gene therapy over manufacturing issues
The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...
Rolling Out1mon
New FDA covid shot warnings nobody is talking about - Rolling Out
Under the new FDA leadership, updated COVID shots are being limited primarily to high-risk individuals including adults over 65 and those with underlying health vulnerabilities.
Fierce Pharma6d
FDA names next CDER director in biotech vet George Tidmarsh
FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and ...
FDA panel to revisit menopausal hormone therapy
MENOPAUSAL THERAPY IN FOCUS — The FDA will hold a panel discussion Thursday on hormone therapy for menopausal women, a pet ...
FDA funding clash looms between Senate, House
Despite the Trump administration’s efforts to shrink the FDA, Senate appropriators unanimously advanced a funding bill ...