Replimune’s Last Chance: FDA Review Of RP1 Melanoma Agent Is Comprehensively Negative; Advisory Committee Represents De Facto Appeal Of CRLs

Prevision Policy Clips | Expedited IND Pilot Program: FDA Will Host Webinar August 6 “To Clarify The Intent Behind The Program”

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