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Golodirsen Approval Package Includes Commitment By Sarepta To Withdraw Vyondys 53 If Confirmatory Trial Does Not Show “Sufficient” Evidence Of Benefit
January 22, 2020
Prevision Policy Clips | OND Reorg: Phase III Launches January 21 With Placeholder Leadership In OTC
January 22, 2020
Early Approvals At FDA: Nearly One-Quarter Of NMEs Beat The User Fee Goal Date By More Than Two Weeks In 2018-2019; New Trend Gaining Steam
January 21, 2020
Prevision Policy Clips | Trump Impatience On Drug Pricing Complicates Finance/IPI Agreement
January 21, 2020
Part D Overhaul Endorsement From MedPAC Coming Soon: Could Boost Pharma-Friendly Legislation For Drug Pricing
January 17, 2020
FDA Committee Splits Over Durect’s Posimir For Post-Op Pain Relief; Agency-Sponsor Dispute Leaves Committee Confused
January 17, 2020
Prevision Policy Clips | FDA Invites Broader Stakeholder Input For Rare Disease Day 2020
January 17, 2020
When To Call ODAC? FDA’s Pazdur Gives Three Reasons
January 16, 2020
Part B Billion Dollar Club: Biosimilar Price Erosion For Infliximab And Growth Of Checkpoint Inhibitors Are Trends In 2018 Medicare Dashboard Data
January 16, 2020
Oncology Pediatric Study Plan Q&A Guidance Tries To Settle Confusion On FDARA Requirement
January 16, 2020
OxyContin “Real World” Abuse Data Again Under Review At FDA: Future Of Opioid Development May Hinge On Outcast Company
January 16, 2020
IPC’s Aximris XR Oxycodone Formula Voted Down By Advisory Committee; Members Implore FDA To Better Define “Abuse-Deterrent” Claims
January 16, 2020
Prevision Policy Clips | FDA Adds Four NDAs To Be “Deemed” BLAs In March
January 16, 2020
Nektar Ends Oxycodegol Program After Historic Rejection By Joint FDA Advisory Committee; Single Efficacy Trial and Unclear Abuse Liability Drive Negative Vote
January 15, 2020
Esteve Tramadol/Celecoxib Combo: Industry Reps Salvage Split Vote By FDA Committee, Preserving Hope That Novel Opioids May Still Be Approvable
January 15, 2020
Prevision Policy Clips | Nektar Withdraws Oxycodegol NDA Hours After Unanimous "No" From FDA Advisory Committee
January 15, 2020
Durect’s Posimir: Contentious Regulatory History Casts Shadow Over Bupivacaine Formulation Heading Into FDA Committee Review
January 14, 2020
Prevision Policy Clips | FDA Office Of New Drugs Reorg “Phase III” Pushed One Week To January 21
January 14, 2020
IPC’s Aximris XR Oxycodone FDA Advisory Committee: Is Intravenous Abuse Deterrence Alone Enough To Support Opioid Approval?
January 13, 2020
Part D Billion Dollar Club In 2018 Comprised 30 Products Representing One-Third Of Program: CMS Dashboard Data Suggests Impact Of Inflation Rebates
January 13, 2020
Esteve Tramadol/Celecoxib Heads To FDA Committee With Straightforward Case For Approval – If Panel Is Willing To Approve New Opioid Combo
January 13, 2020
Prevision Policy Clips | FDA Biomarker “Concepts and Terminology” Workshop March 23
January 13, 2020
Nektar Oxycodegol Re-Starts Opioid Reviews: FDA Makes Case For More Approvals – But Not Necessarily This NDA; Single Efficacy Trial Could Be Hurdle
January 10, 2020
Prevision Policy Clips | Blueprint Medicines’ Ayvakit Is First NME Approval Of 2020
January 10, 2020
Prevision Policy Clips | CDER Director Janet Woodcock To Advocate For "Smart, More Inclusive" Drug Development
January 9, 2020
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