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Pfizer Faces Skeptical FDA For Talzenna “All Comers” Prostate Cancer Indication, But Can ODAC Say No To Survival Benefit?

May 16, 2025

Janssen Darzalex Faspro For Smoldering Myeloma: PFS Benefit In “Precursor” Condition Doubted By FDA Ahead Of ODAC; New CBER Director Prasad Is Also A Skeptic

May 16, 2025

Genentech Columvi Confirmatory Trial Questioned By FDA; ODAC Will Be Asked If Positive Results Apply To US Population Given Impact Of China/Asia Patients On Efficacy Outcomes

May 16, 2025

Prevision Policy Clips | GDUFA IV Reauthorization Kick-Off Meeting Set For July 11, FDA Formally Announces July 14 PDUFA VIII Public Meeting

May 16, 2025

Prevision Policy Clips | Biohaven Troriluzole For SCA Will Go Before An FDA Advisory Committee

May 15, 2025

RFK Embraces Streamlined Development Path For New Drugs During Budget Hearings; Says Industry 340B Concerns Need Attention, But Pledges To Protect Rural Providers

May 14, 2025

CMMI Will Look To More Drug Demos In Future Years, Sickle Cell Gene Therapy Model May Be Blueprint For Drugs That Get At “Root Causes” Of Conditions

May 14, 2025

Prevision Policy Clips | Finance Committee PBM Legislation Will Advance Following Reconciliation Process, Sen. Grassley (R-Iowa) Says

May 14, 2025

CMS Outlines Medicare Drug Price Re-Negotiation Process; Few Of First 25 Products Likely To Be Eligible – But Xarelto And Tradjenta May Be

May 13, 2025

Medicare Price Negotiation Year 3: CMS Proposes Tweaks But No Major Revisions, Suggests Biologic SubQ Combos May Not Be Separate From Original Brand

May 13, 2025

CBER Touts Cell/Gene Therapy “Platform Technology,” CMC Pilot To Speed Development; Others Float Public Cost Recovery Model For Rare Diseases

May 13, 2025

Prevision Policy Clips | Price Negotiation For Year 3: CMS Leaves Key Product Selection Criteria Unchanged In Draft Guidance

May 13, 2025

Drug Manufacturers Get Some Of What They Want In House Reconciliation Bill: Orphan Drugs Get A Reprieve; PBM Reforms Are Present, “Pill Penalty” Fix Is Absent

May 12, 2025

MFN Policy 2.0: Manufacturers Have 30-Day Window To Avoid New Pricing Rules Via Direct-To-Consumer Sales; International Price “Equalization” Is Goal

May 12, 2025

Prevision Policy Clips | MFN Policy 2.0: Manufacturers Have A Chance To “Negotiate”

May 12, 2025

Prevision Policy Clips | FDA TV? Commissioner Makary, CBER Director Prasad

May 9, 2025

Pushing AI At FDA: Agency Plans “Aggressive” Rollout For AI Platform To Aid “Scientific Review”; Commissioner Cites First “AI-Assisted” Review Milestone

May 8, 2025

Prevision Policy Clips | PDUFA Reauthorization Kick Off Meeting Set For July 14

May 8, 2025

Opioid Post-Marketing Studies Praised For “Rigor,” But FDA Committee Wary Of Labeling Changes; Discussion Highlights Ongoing Concerns About Long-Term Efficacy

May 7, 2025

HHS Deputy Nominee O’Neill Cites Value Of AI, Support For Medicare Drug Price Negotiation And Vaccines During Confirmation Hearing; RFK “Doing A Great Job”

May 7, 2025

Prevision Policy Clips | FDA Schedules Last-Minute ODAC Review Of Four Oncology Drugs May 20-21

May 7, 2025

CBER Director Vinay Prasad Solidifies FDA’s Anti-Industry Identity, Brings Increased Scrutiny To Use Of Accelerated Approval In Cancer, Gene Therapies

May 6, 2025

White House Drug Manufacturing EO Seeks To Streamline Domestic Site Inspections, Accelerate Foreign Audits – But RIFs, Long-Standing Challenges Will Be Reality Check

May 6, 2025

Prevision Policy Clips | FDA Directed To Streamline Domestic Inspections, Accelerate Foreign Ones

May 6, 2025

Prevision Policy Clips | FDA Not Mentioned In “Skinny Budget” Unveiled By Trump Administration May 2

May 5, 2025
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