Disease or Syndrome

Regeneron Reports Phase 3 Success for Cemdisiran in Rare Disease Generalized Myasthenia Gravis

12 hours ago talkbio0Tagged Alnylam, cemdisiran, Infrequent, Myasthenia Gravis, Generalized, Regeneron, regulatory submission, RNA drug, RNA, Small Interfering, United States

Regeneron; Phase 3 trial; cemdisiran; generalized myasthenia gravis; rare disease; RNA drug; siRNA; Alnylam Pharmaceuticals; U.S. regulatory submission

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

12 hours 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

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

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

2 days 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

Dynavax Highlights Comparable Efficacy and Improved Tolerability of Z-1018 Shingles Vaccine vs. Shingrix

5 days ago talkbio0Tagged aspects of adverse effects, Dynavax, Effectiveness, Herpes zoster disease, Immunogenicity (package insert), Shingrix, Vaccines, Z-1018

Dynavax; Z-1018; shingles vaccine; Shingrix; vaccine efficacy; side effects; Phase 1/2 trial; immunogenicity

AbbVie’s Rinvoq Achieves Second Phase 3 Win in Alopecia Areata Trials

5 days ago talkbio0Tagged AbbVie, Alopecia, Eyebrow structure, Eyelash, hair regrowth, Rinvoq, safety profile, Salts, Score, upadacitinib

AbbVie; Rinvoq; upadacitinib; alopecia areata; Phase 3 clinical trial; hair regrowth; SALT score; eyebrows; eyelashes; safety profile

AbbVie’s Rinvoq Achieves Strong Phase 3 Results in Alopecia Areata, Clearing Key Efficacy Milestone

6 days ago talkbio0Tagged AbbVie, Alopecia, hair regrowth, Inhibitor, Janus kinase, Rinvoq, Salts, Score, upadacitinib

AbbVie; Rinvoq; Phase 3 trial; alopecia areata; hair regrowth; upadacitinib; SALT score; JAK inhibitor

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

6 days 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

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

7 days 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

American Academy of Pediatrics Breaks with RFK Jr., CDC on COVID Vaccines for Kids

7 days ago talkbio0Tagged Academy of Pediatrics, antiarrhythmic peptide, Centers for Disease Control and Prevention (U.S.), Child, COVID19 (disease), Immunization, Pediatric brand name, Policy, public health guidance, Robert F. Kennedy, Vaccines

American Academy of Pediatrics; AAP; COVID-19 vaccine; children; CDC; Robert F. Kennedy Jr.; pediatric immunizations; public health guidance; vaccine policy