News

PharmExec1d
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 ...
Fierce Pharma12d
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 ...
foxbaltimore1mon
FDA announces sweeping changes to Drug Review process - WBFF
WASHINGTON (TNND) — The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10-12 months ...
Seattle Times2mon
WA vaccine scientists push back against FDA changes around COVID shots
WA vaccine scientists push back against FDA changes around COVID shots . May 21, 2025 at 6:00 am Updated May 21, 2025 at 6:01 am . By . Elise Takahama. Seattle Times staff reporter.