PDUFA
FDA delays decision date on Cytokinetics’ heart drug to year-end in unusual safety program back-and-forth
Cytokinetics, aficamten, FDA delay, PDUFA date extension, hypertrophic obstructive cardiomyopathy (oHCM), Risk Evaluation and Mitigation Strategy (REMS), regulatory setback
FDA delays PDUFA date for small biotech, raising questions about impact of agency cuts
United States Food and Drug Administration, PDUFA, Impact food supplement, Approved, Agencies, questions
Massive FDA Staff Cuts Jeopardize Drug and Device Review Processes, Threatening Critical User Fee Programs
FDA layoffs , Drug review delays , User Fee Programs , PDUFA , Regulatory challenges , FDA budget cuts , Medical device approval , Biopharma regulatory issues , RFK Jr. HHS layoffs , FDA operational disruptions
FDA to Decide on Merck’s Subcutaneous Keytruda in September 2025
Subcutaneous Keytruda, FDA decision, September 23, 2025, Merck & Co., cancer treatment, PDUFA date
FDA Delays Decision on Full Approval for Amgen’s Lumakras and Intercept’s Ocaliva
FDA, PDUFA, Amgen, Intercept, Lumakras, Ocaliva, metastatic colorectal cancer, primary biliary cholangitis
FDA Decision on Vertex’s Non-Opioid Analgesic Suzetrigine Due Early Next Year
FDA, Vertex, Suzetrigine, Non-Opioid Analgesic, Acute Pain, PDUFA, Priority Review
FDA Delays Dupixent Decision for COPD by Three Months, EMA Recommends Approval
FDA, Dupixent, COPD, EMA, Regeneron, Sanofi, Priority Review, PDUFA, Boreas, Notus, Phase III Trials
Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval
Bristol Myers Squibb, KRAZATI (adagrasib), Pivotal Phase 3 trial, KRYSTAL-12 study, Primary endpoint met, Progression-free survival (PFS), Overall response rate (ORR), Confirmatory trial, Non-small cell lung cancer (NSCLC), Locally advanced or metastatic, KRASG12C mutation, Accelerated approval, Continued approval contingent on clinical benefit verification, FDA assigned PDUFA goal date of June 21/ 2024
Bayer Acquires European Rights to BridgeBio’s Acoramidis for ATTR-CM Therapy
Bayer, BridgeBio Pharma, Acoramidis, ATTR-CM, Exclusive License, European Rights, Royalties, Milestone Payments, Phase 3 Data, Potential Approval, Low-Thirties Percent Royalties, EMA Approval 2025, PDUFA Action Date November 2024, Vyndaqel Rival, Blockbuster Potential, Cardiovascular Infrastructure, Investor Hopes for Clarity on Split Strategy.