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PharmExec5m
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 ...
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 ...
100 days into the job, FDA head talks to CNN about agency goals— and Coke’s switch to sugar
Marty Makary says the FDA will plow ahead with big plans on ultra processed foods, dietary guidelines, and expedited drug and ...
FDA Commissioner: 100 Days of Change—Modernizing the FDA for a Healthier America | Opinion
The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...
BioSpace1d
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 Rejects Replimune’s Skin Cancer Treatment, Shares Sink
Replimune Group Inc. shares sank to their lowest point ever after US regulators rejected a skin cancer treatment from the ...
Fierce Pharma3d
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 ...
BioSpace2d
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 ...
FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...
Fierce Pharma11d
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 ...
JD Supra1mon
Staying Prepared Amid FDA Changes | Gardner Law - JDSupra
Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory ...