PDUFA – Talk Bio

Massive FDA Staff Cuts Jeopardize Drug and Device Review Processes, Threatening Critical User Fee Programs

2 weeks ago talkbio0Tagged Biopharma regulatory issues, Budgets, delays, drug review, HHS layoffs, layoffs, Medical Devices, operational, PDUFA, regulatory, RFK Jr., United States Food and Drug Administration, user fee

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

4 weeks ago talkbio0Tagged 2025, Cancer Therapeutic Procedure, Co., Decision, Merck & Co., PDUFA, September 23, Subcutaneous Keytruda, United States Food and Drug Administration

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

6 months ago talkbio0Tagged amgen, Biliary Cholangitis, Intercept Substance, Lumakras, Metastasis from malignant neoplasm of colon and/or rectum, Ocaliva, PDUFA, United States Food and Drug Administration

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

9 months ago talkbio0Tagged Acute onset pain, Analgesics, Non-Opioid, PDUFA, Priority Review, Suzetrigine, United States Food and Drug Administration, Vertex

FDA, Vertex, Suzetrigine, Non-Opioid Analgesic, Acute Pain, PDUFA, Priority Review

FDA Delays Dupixent Decision for COPD by Three Months, EMA Recommends Approval

11 months ago talkbio0Tagged Boreas, Chronic Obstructive Airway Disease, Dupixent, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Notus, PDUFA, Phase 3 Clinical Trials, Priority Review, Regeneron, sanofi, United States Food and Drug Administration

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

1 year ago talkbio0Tagged Accelerated Approval, adagrasib, Approved, bristol-myers, Clinical Benefit, Confirmatory Trial, Continuous, June 21/ 2024, KRASG12C mutation, KRAZATI, KRYSTAL-12, Locally, Metastatic to, Non-Small Cell Lung Carcinoma, ORR, Overall response rate, PDUFA, Primary Endpoint, Progression-Free Survival, squibb, United States Food and Drug Administration, Verification of Theories

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

1 year ago talkbio0Tagged 2025, Acoramidis, Approved, ATTR-CM, Bayer, Blockbuster Potential, BridgeBio Pharma, Cardiovascular Infrastructure, Clarity, Clinical action, EMA Approval, European Rights, Exclusive License, Hope (emotion), investor, low-thirties, milestone payments, November 2024, PDUFA, Phase 3 Data, royalties, Split Strategy, Vyndaqel Rival

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.