United States Food and Drug Administration – Page 20

Who Is Making AI Work in Drug R&D in 2025?

4 months ago talkbio0Tagged Advice, Artificial Intelligence, Big Pharma, biopharma startups, Clinical Trials, Drug Development, Efficiency, Precision Medicine, United States Food and Drug Administration

AI drug discovery; Big Pharma; biopharma startups; clinical trials; FDA guidance; personalized medicine; drug development efficiency

Lilly to Seek Global Approval for GLP-1 Pill After Obesity and Diabetes Trial Success

4 months ago talkbio0Tagged Approved, Clinical Trials, Contraceptives, Oral, Diabetes Mellitus, Non-Insulin-Dependent, Eli, Eli Lilly, Glucagon-Like Peptide 1, Obesity, orforglipron, United States Food and Drug Administration, Weight Loss

Eli Lilly; GLP-1 pill; orforglipron; obesity; type 2 diabetes; FDA approval; weight loss; clinical trial

Akeso, Summit’s PD-1xVEGF Drug Ivonescimab Shows Strong Progression-Free Survival Benefit in Global Lung Cancer Trial

4 months ago talkbio0Tagged Akeso, Antibodies, Bispecific, Approved, Ivonescimab, Non-Small Cell Lung Carcinoma, Overall Survival, PD-1xVEGF, Phase 3 trial, Progression-Free Survival, summit, United States Food and Drug Administration

Akeso; Summit Therapeutics; ivonescimab; PD-1xVEGF; bispecific antibody; non-small cell lung cancer; progression-free survival; Phase 3 trial; overall survival; FDA approval

Argenx’s Vyvgart Shows Positive Phase 3 Results in Seronegative Myasthenia Gravis

4 months ago talkbio0Tagged AChR-Ab, Adaptation, Argenx, expansion, Labels (device), LRP4 gene, Musk, Myasthenia Gravis, Phase 3, SERON, Seronegative, triple seronegative, United States Food and Drug Administration, Vyvgart

Vyvgart; Argenx; Phase 3; myasthenia gravis; seronegative; ADAPT SERON; AChR-Ab; MuSK+; LRP4+; triple seronegative; FDA label expansion

Argenx Prepares FDA Filing to Expand Vyvgart Use in Myasthenia Gravis After Late-Stage Trial Win

4 months ago talkbio0Tagged Approved, Argenx, Clinical Trials, Myasthenia Gravis, Myasthenia Gravis, Generalized, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Self-injection, Syringes, United States Food and Drug Administration, Vyvgart

Argenx; Vyvgart; FDA approval; myasthenia gravis; prefilled syringe; self-injection; chronic inflammatory demyelinating polyneuropathy; generalized myasthenia gravis; clinical trial

FDA Begins Daily Publication of Drug Adverse Event Data

4 months ago talkbio0Tagged Adverse event, Daily, data modernization, drug safety, FAERS, public health medicine (field), real-time monitoring, United States Food and Drug Administration

FDA; FAERS; adverse event reporting; daily publishing; data modernization; drug safety; real-time monitoring; public health

FDA Suspends Valneva’s Chikungunya Vaccine, Ixchiq, Due to Serious Safety Concerns

4 months ago talkbio0Tagged Adverse event, Cessation of life, chikungunya vaccine, Encephalitis, Hospitalization, Ixchiq, license suspension, Safety, United States Food and Drug Administration, Valneva

FDA; Valneva; Ixchiq; chikungunya vaccine; license suspension; safety; serious adverse events; encephalitis; hospitalizations; deaths

FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues

4 months ago talkbio0Tagged Biosimilars, Deferred, Edema, Eylea HD, macular, manufacturing issues, Nordisk facility, Pre-filled Syringe, Regeneron, regulatory approval, Retinal Vein Occlusion, United States Food and Drug Administration

FDA delay; Regeneron; Eylea HD; manufacturing issues; Novo Nordisk facility; biosimilars; pre-filled syringe; macular oedema; retinal vein occlusion; regulatory approval

Nucleus RadioPharma Appoints Former FDA Commissioner Dr. Stephen Hahn as CEO

4 months ago talkbio0Tagged Appointments, biotech leadership, Cancer Therapeutic Procedure, CEO, Commissioner, Hahn, Nucleus RadioPharma, Radiopharmaceuticals, supply chain, United States Food and Drug Administration

Nucleus RadioPharma; Stephen Hahn; FDA Commissioner; CEO appointment; radiopharmaceuticals; cancer therapy; supply chain; biotech leadership

FDA Lifts Hold on Rocket Pharmaceuticals’ Pivotal Gene Therapy Study at Lower Dose

4 months ago talkbio0Tagged C3 complement inhibitor, Capillary Leak Syndrome, Dosage, gene therapy, Glycogen Storage Disease Type IIb, Individual Adjustment, Phase 2 Clinical Trials, Rocket, RP-A501, Study on Hold, United States Food and Drug Administration

FDA; Rocket Pharmaceuticals; gene therapy; Danon disease; clinical hold; RP-A501; dose adjustment; C3 complement inhibitor; capillary leak syndrome; patient death; Phase II trial