Temporal Concept – Page 10

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

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 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

FDA Extends PDUFA Date for Regenxbio’s Hunter Syndrome Gene Therapy RGX-121

4 months ago talkbio0Tagged clemidsogene lanparvovec, Deferred, gene therapy, IDS gene, Infrequent, Mucopolysaccharidosis II, PDUFA, Regenxbio, RGX-121, United States Food and Drug Administration

FDA delay; PDUFA extension; Regenxbio; Hunter syndrome; clemidsogene lanparvovec; RGX-121; gene therapy; Mucopolysaccharidosis II; IDS gene; rare disease

Stealth BioTherapeutics Resubmits Third FDA Application for Rare Disease Drug

4 months ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, access program, Drug Approval, Elamipretide, Infrequent, resubmission, Stealth BioTherapeutics, United States Food and Drug Administration

Stealth BioTherapeutics; FDA resubmission; rare disease; Barth syndrome; elamipretide; drug approval; expanded access program

FDA Approves Tonix’s Tonmya: First New Fibromyalgia Drug in Over 15 Years

4 months ago talkbio0Tagged Analgesics, Non-Narcotic, Approved, Chronic pain, Clinical Trials, cyclobenzaprine, Fibromyalgia, Hairy Cell Leukemia, Phase 3, sublingual tablets, Tonix, Tonmya, United States Food and Drug Administration

Tonmya; FDA approval; fibromyalgia; Tonix Pharmaceuticals; non-opioid analgesic; cyclobenzaprine HCl sublingual tablets; chronic pain; phase 3 clinical trials

FDA Grants Full Approval to Precigen’s Papzimeos for Rare Disease RRP

4 months ago talkbio0Tagged Approved, Episodic, gene therapy, Immunotherapy, Infrequent, orphan drug designation, Papzimeos, Precigen, Recurrent respiratory papillomatosis, RRP, United States Food and Drug Administration

Precigen; Papzimeos; FDA approval; recurrent respiratory papillomatosis (RRP); gene therapy; immunotherapy; rare disease; Orphan Drug designation

HHS Revives ’90s-Era Task Force to Improve Childhood Vaccine Safety

4 months ago talkbio0Tagged Adverse reactions, Advisory Committees, Centers for Disease Control and Prevention (U.S.), CHARGE Syndrome, Childhood, Childhood Vaccines, Jay Bhattacharya, NIH Mouse, Robert F. Kennedy Jr., United States Food and Drug Administration, Vaccine Safety, Vaccines

HHS; childhood vaccines; vaccine safety; task force; Robert F. Kennedy Jr.; Jay Bhattacharya; NIH; FDA; CDC; vaccine oversight; adverse reactions; childhood immunization schedule

Precigen Receives FDA Approval for First Immunotherapy for HPV-Related Recurrent Respiratory Papillomatosis

4 months ago talkbio0Tagged Adenovirus Vector, Approved, Episodic, gene therapy, human papillomavirus, Identifier, Immunotherapy, Papzimeos, Precigen, Recurrent respiratory papillomatosis, RRP, United States Food and Drug Administration, zopapogene imadenovec-drba

Precigen; FDA approval; Papzimeos; zopapogene imadenovec-drba; HPV; recurrent respiratory papillomatosis (RRP); immunotherapy; gene therapy; adenoviral vector; Breakthrough Therapy designation

Fierce Biotech Layoff Tracker 2025: Abata Folds; Generation Lays Off 90% of Staff

4 months ago talkbio0Tagged Abata, Biotech Layoff Tracker, Biotech Layoffs, company closure, Fierce, Generations, Staff

biotech layoffs; Abata; Generation; Fierce Biotech Layoff Tracker; 2025; company closure; staff reduction