News

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 ...
PharmExec11h
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 Executive To Oversee U.S. Drug Program
FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...
BioSpace2d
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 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 ...
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 ...
Fierce Pharma4d
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’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 getting better, and use is not mandatory.
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 ...
Livewire Markets10d
When the market’s hot, go where it’s not: Biotech’s position of opportunity for FY26
Biotech stumbled in FY25, but we didn’t. HB Biotechnology kept its footing and delivered 23% outperformance in a tough market ...
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 ...
AOL2mon
FDA plans to limit COVID shots to those over 65 or with high-risk ...
In a major policy change, the Food and Drug Administration has announced a plan to limit access to future COVID-19 shots only to people over 65 years old or those with an underlying health condition.