Drug Approval
FDA Launches New Priority Review Voucher Program Aligned with National Priorities
FDA; priority review voucher; CNPV; biopharma; drug approval; national priorities; accelerated review; unmet public health needs
FDA Delays Decision on KalVista’s HAE Drug Sebetralstat, Citing Heavy Workload
KalVista Pharmaceuticals; sebetralstat; FDA delay; hereditary angioedema; resource constraints; PDUFA date; drug approval; oral on-demand treatment
FDA Leaders Anticipate Imminent Drug Approval Decisions
FDA; drug approval; PDUFA date; regulatory decision; upcoming approvals; FDA leadership
FDA’s medical review departments remain largely untouched (for now) by Musk-led cuts
FDA, medical review, drug approval, device regulation, staff cuts, Elon Musk, DOGE, government efficiency
FDA Delays Decision on Stealth BioTherapeutics’ Elamipretide for Barth Syndrome Until April 2025
Barth Syndrome, Elamipretide, FDA Decision, Stealth BioTherapeutics, Drug Approval Delay
Appeals Court Upholds FDA’s Denial of Fast Track Designation for Vanda’s Gastroparesis Drug
FDA, Vanda Pharmaceuticals, Fast Track Designation, Gastroparesis, Drug Approval Process
FDA Introduces New Guidance on AI for Drug Approval Submissions in 2025
FDA, AI, drug approval, guidance, regulatory decision-making, medical devices, artificial intelligence, drug development
FDA Advisory Committee Rejects Lexicon’s Zynquista for Type 1 Diabetes and Chronic Kidney Disease
FDA, Lexicon Pharmaceuticals, Zynquista, sotagliflozin, type 1 diabetes, chronic kidney disease, FDA advisory committee, drug approval
European Commission’s Reconsideration of Translarna’s Marketing Authorization: A Critical Turning Point for Duchenne Muscular Dystrophy Treatment
Translarna, Duchenne muscular dystrophy, European Commission, EMA, CHMP, conditional marketing authorization, drug approval, regulatory decisions
FDA Raises Concerns Over Stealth BioTherapeutics’ Ultra-Rare Disease Drug Ahead of Advisory Committee Meeting
FDA, Stealth BioTherapeutics, elamipretide, Barth syndrome, ultra-rare disease, advisory committee meeting, drug approval, efficacy concerns