Drug Approval – Talk Bio

FDA Rejects Biohaven’s Ataxia Drug Vyglxia, Forcing Company to Cut Costs After Second Approval Failure

4 days ago talkbio0Tagged Ataxia, Spinocerebellar, Biohaven, Clinical Trial Design, Drug Approval, external controls, IL31RA gene, In complete remission, R&D, Rejection, Troriluzole, United States Food and Drug Administration, Vyglxia

Biohaven; FDA rejection; Vyglxia; troriluzole; spinocerebellar ataxia; CRL (Complete Response Letter); clinical trial design; external controls; drug approval; R&D cuts

Recent News: Live at 11 a.m. ET – M&A, FDA, MFN and Collaboration with FT

5 days ago talkbio0Tagged Acquisitions, Drug Approval, Economics, Financial Times, Live - Specimen Condition, M&A, mergers, MFN, News [Publication Type], United States Food and Drug Administration

M&A; FDA; MFN; Financial Times; mergers and acquisitions; drug approval; economics; live news

FDA Staffing Data Reveal Historic Departures in Fiscal 2025

3 weeks ago talkbio0Tagged CBER, CDER, departures, Disruption, Drug Approval, fiscal, layoffs, Organization administrative structures, Regulatory Impact, United States Food and Drug Administration, Workforce - population group

FDA; staffing; departures; fiscal 2025; layoffs; regulatory impact; CDER; CBER; drug approval delays; organizational disruption

FDA Announces First Recipients of Makary’s National Priority Voucher Program, Expanding Scope for Accelerated Drug Reviews

3 weeks ago talkbio0Tagged Accelerated, CNPV, domestic drug manufacturing, Drug Approval, Martin Makary, National Priority Voucher, pilot program, Priority Review, public health crisis, recipients, United States Food and Drug Administration

FDA; National Priority Voucher; CNPV; Martin Makary; priority review; accelerated drug approval; 2025 pilot program; voucher recipients; public health crisis; domestic drug manufacturing

FDA Drug Approvals in 2025 Remain Within Recent Averages Amid Agency Upheaval

4 weeks ago talkbio0Tagged 2025, CBER, CDER, Drug Approval, molecular entities, trends qualifier, United States Food and Drug Administration

FDA; drug approvals; 2025; new molecular entities; CDER; CBER; trends; novel drugs

FDA Launches Pilot Program to Prioritize U.S. Generic Drug Manufacturing and Testing

1 month ago talkbio0Tagged ANDA, bioequivalence testing, domestic manufacturing, Drug Approval, Pharmaceutical Supply Chain, pilot program, Prioritization, resilience, supply chain, United States, United States Food and Drug Administration

FDA; pilot program; generic drugs; ANDA prioritization; domestic manufacturing; bioequivalence testing; U.S. pharmaceutical supply chain; drug approval; supply chain resilience

Vanda Ends Lawsuits Against FDA in Broad Settlement, Paving Way for Drug Review Progress

1 month ago talkbio0Tagged Clinical Trials, collaborative framework, Drug Approval, Employment Termination, Hetlioz, jet lag disorder, lawsuit, Motion Sickness, sNDA, Tradipitant, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; FDA; Hetlioz; jet lag disorder; tradipitant; lawsuit dismissal; collaborative framework; clinical trial hold; drug approval; sNDA; motion sickness

Fortress Biotech and Sentynl Therapeutics Fail to Secure FDA Approval for CUTX-101 in Rare Pediatric Menkes Disease

1 month ago talkbio0Tagged biotech, Complete, CUTX-101, deficiencies, Drug Approval, Fortress, Infrequent, Manufacturing, Menkes disease, Pediatric Disorder, Sentynl Therapeutics, United States Food and Drug Administration

Fortress Biotech; Sentynl Therapeutics; FDA Complete Response Letter; CUTX-101; Menkes disease; rare pediatric disease; manufacturing deficiencies; drug approval setback