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Price Negotiation Year Two: CMS Revamps Patient Input Process In Final Guidance, But Leaves Key Policies Unchanged, Including Hands-Off Approach To 340B
October 3, 2024
Prevision Policy Clips | CMS Revamps Patient Input Process For Price Negotiation Round Two
October 3, 2024
Prevision Policy Clips | FDA’s Office Of Inspections And Investigations Is Official
October 2, 2024
Realigning Drug R&D: FDA’s Cavazzoni Sees No “Magic Wand” To Encourage Innovation For More Common Diseases, Suggests IRA Is One Factor To Weigh
October 1, 2024
Prevision Policy Clips | AZ Andexxa Confirmatory Trial Will Be Reviewed By CBER Advisory Committee Nov. 21
October 1, 2024
FDA’s Global Strategy Needs To Be “Revitalized” With A More Transparent Global Supply Chain And Better Purchasing Behavior From Drug Companies, Califf Says
September 30, 2024
ATTR-CM New Entrants: ICER Impressed With Activity Of BridgeBio’s Acoramidis, Alnylam’s Vutrisiran; High Costs Are Concern, Especially For Combination Use
September 30, 2024
Prevision Policy Clips | HRSA Threatens Sanctions On J&J Over Proposed 340B “Rebate” Program
September 30, 2024
Advisory Committee Tracker: Stealth Bio Barth Syndrome Resubmission Heads To Panel; Applied Sciences Galactosemia NDA Will Not Need GeMDAC After All
September 27, 2024
PDL-1 “Negative” Patients Likely To Be Cut From Checkpoint Inhibitor Labels In GI, Esophageal Cancer; Keytruda (Merck), Opdivo (Bristol), Tevimbra (BeiGene) Affected
September 27, 2024
Merck, Bristol, BeiGene Urged To Support Biomarker Collaboration By OCE Director Pazdur During ODAC Review Of Proposed Label Restrictions
September 27, 2024
Prevision Policy Clips | Bristol-Myers Cobenfy Schizophrenia Approval
September 27, 2024
Gene Therapy “Now” Or “Die Waiting”? CBER Patient Listening Session Underscores Difficult Choices, FDA Focus On Long-Term Follow-Up And “Timely” Communications
September 27, 2024
FDA Rare Disease “Hub” Organization Builds On Existing Review Divisions Within CBER, CDER; Stability Will Benefit Application Reviews, CBER’s Tierney Says
September 26, 2024
Prevision Policy Clips | Pfizer Withdraws Sickle Cell Disease Drug Oxbryta Due To “Totality Of Clinical Data”
September 26, 2024
Senate HELP Chair Sanders Springs PBM Surprise On Novo At Hearing, But CEO Gives Strong Performance Under Pressure; International Reference Pricing Gets Cameo
September 25, 2024
Prevision Policy Clips | CBER AA For Rare Disease Gene Therapies Guidance Will Offer “Clear Expectations” On Data Required To Support Endpoints
September 25, 2024
Checkpoint Inhibitor Cut Points: ODAC Will Hear Case For Biomarker-Based Indications; Esophageal Relabeling May Be More Likely Than GI; Merck, Bristol, BeiGene To Present
September 24, 2024
Prevision Policy Clips | Rare Pediatric Disease Priority Review Voucher Reauthorization Bill Passes House
September 24, 2024
Medicaid Rebates: CMS Drops Price “Verification,” Rebate “Stacking” Proposals; “Misclassification” Policy Finalized Along With Other Technical Changes
September 23, 2024
Pertussis Challenge Models Are “Promising,” FDA Panel Agrees, But May Not Be Ready For Pivotal Efficacy Trials; Increasing Vaccination In Pregnancy May Be More Immediate Priority
September 23, 2024
Prevision Policy Clips | FDA Pediatric Voucher Program Would Be Extended To December 20 Under Continuing Resolution
September 23, 2024
Prevision Policy Clips | Patent Reform Bill Votes Postponed In Senate Judiciary Committee, Chair Dick Durbin (D-Ill.) Says
September 20, 2024
Re-Aligning R&D Incentives: CMS NTAP Program Offers Model For Encouraging Clinical Superiority Data, NASEM Committee Told
September 19, 2024
FDA Oncology Office Cautions Sponsors About Pitfalls Of Open-Label RCTs In Journal Article; Lumakras Is One Object Lesson
September 19, 2024
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