End Of The Line For Deramiocel? FDA Finds No Benefit In DMD Cardiomyopathy In Resubmitted BLA, But Advisory Committee May Be More Flexible

FDA’s Compound Headache: Advisory Committee Peptide Votes Put Agency In A Quandary As It Navigates Kennedy And The Courts; Warning Sign Of How Other Committees Could Be Politicized?

Prevision Policy Clips | FDA And Peptides: What Happens Now?

Prevision Policy Clips | CDC Nominee Schwartz Has Support Of HELP Chair Cassidy But Vote Delayed

CMC Readiness Pilot Winds Down: FDA Will Allow Additional CMC-Focused Meetings For Expedited Products Going Forward

Country-Of-Origin Labeling Bill Clears Senate HELP Committee, As FDA/Drug Pricing Bills Advance In Both Chambers; Insulin Bill May Be Complicated By 340B Issues

Prevision Policy Clips | Revolution Medicines’ Daraxonrasib Filing Accepted By FDA; How Quickly Will Agency Act?

FDA Hiring Pipeline Includes Nearly 900 New Recruits, Deputy Zeta Says, But Process “Is Not Quick”; Diamantas Underscores Support For Staff

Prevision Policy Clips | Generic Drug Tariffs? President Trump Says He Plans 100% Tariff In August 2028

Prevision Policy Clips | US Versus China In Oncology Innovation: FDA Maintains Faster Approval Timelines, More First In Class Approvals

Pediatric Antihypertensives: FDA Wants More Adult Drugs Labeled For Kids; PK Studies, Safety Registries Could Help Address Knowledge Gaps

Clinical Research Incubators: Ex-FDAer Woodcock Says Research Sites Should Be Nurtured As Important Economic Sector

Prevision Policy Clips | “Expedited IND” Pilot: FDA Extends Comment Period Until August 24

Prevision Policy Clips | Senate HELP Committee to Vote on CDC, ASPR Nominees July 23

FDA, Industry Support Advancing Evidentiary Framework To Guide Biomarker Development; Agency Encourages Sponsors To Take The Lead

OS In Oncology: FDA Message On Planning For Safety Analyses Appears To Be Getting Through; Is It Time To Separate Interim OS Analyses From Primary Endpoint Readout?

Building On “Operation TrialBlazer”: Risk-Based Approaches For INDs, User Fees For Chinese Inspections Among Ideas Discussed At House E&C Hearing

Prevision Policy Clips | CDC Nominee Ducks Questions About Authority To Act Independently Of Kennedy

Prevision Policy Clips | GAO Review Of FDA Layoffs And User Fees Requested By House Democrat

Prevision Policy Clips | PACCARB to Discuss Microbiome, Novel Interventions September 9-10

Vera Trutakna Launches At Premium Price To Voyxact In IgAN Category Where Treatment Duration Is Open Question; Another Smooth Accelerated Approval In Class

FDA Releases Fresh Batch Of “Complete Response” Letters For Unapproved Products After “Pause”; Inspections Remain Top Reason For Rejections

Psychedelic Medicines In The Real World: FDA Public Hearing Will Focus On Issues Beyond Approvability Of New Mental Health Therapies; Development Guidance Finalized

Prevision Policy Clips | CDER Achieves First Staff Net Gain Of Fiscal 2026

FDA Offers “Streamlined” Distributed Manufacturing Facility Registration In Proposed Rule; Policy Is Intended To Further Promote Onshoring Efforts