Disease or Syndrome – Page 3

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

1 week 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 Wegovy 3rd Indication: First GLP-1 Approved for MASH with Moderate-to-Advanced Liver Scarring

1 week ago talkbio0Tagged Accelerated, Approved, Fibrosis, Liver, MASH, noncirrhotic, Nordisk, Product containing glucagon-like peptide 1 receptor agonist (product), semaglutide, United States Food and Drug Administration, Wegovy

Wegovy; FDA approval; MASH; semaglutide; GLP-1 receptor agonist; liver fibrosis; Novo Nordisk; ESSENCE trial; noncirrhotic; accelerated approval

FDA Delays Draw Contrasting Responses: Neurizon Cites Agency Strain, Omeros Takes Softer Tone

1 week ago talkbio0Tagged agency staffing shortages, Amyotrophic Lateral Sclerosis, delays, narsoplimab, NUZ-001, Omeros Corporation, regulatory review, Study on Hold, Transplantation, United States Food and Drug Administration

FDA delays; Neurizon Therapeutics; Omeros Corporation; regulatory review; NUZ-001; narsoplimab; ALS; transplant drugs; agency staffing shortages; clinical hold

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

2 weeks 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

2 weeks 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

Sarepta Sells $174 Million Stake in Arrowhead to Fund Milestone Payment Amid Cash Crunch

2 weeks ago talkbio0Tagged Arrowhead, Cash Crunch, Collaboration, milestone payment, Myotonic Dystrophy, private block trade, RNA Interference, SRP-1003, stake sale

Sarepta Therapeutics; Arrowhead Pharmaceuticals; cash crunch; stake sale; milestone payment; RNAi collaboration; SRP-1003; myotonic dystrophy; private block trade

Eli Lilly and Superluminal Ink $1.3B Pact Targeting GPCRs in Obesity, Cardiometabolic Diseases

2 weeks ago talkbio0Tagged Aortic Valve Insufficiency, cardiometabolic diseases, Eli, Eli Lilly, equity, GPCRs, Investments, MC4R, MC4R protein, human, milestones, Obesity, Partnership, Superluminal Medicines

Eli Lilly; Superluminal Medicines; GPCRs; obesity drugs; cardiometabolic diseases; AI drug discovery; MC4R; partnership; milestones; equity investment

CytomX Continues Phase I ADC Study After Patient Death

2 weeks ago talkbio0Tagged ADC, Clinical Trials, Colorectal Carcinoma, CX-2051, CytomX, Kidney Failure, Acute, Patient Death, Phase I, Safety, therapeutic autologous dendritic cells, United States Food and Drug Administration

CytomX; CX-2051; Phase I; ADC; colorectal cancer; patient death; acute kidney injury; clinical trial; safety; FDA; trial continuation

NIH and HHS Cancel Major mRNA Vaccine Research Funding, Citing Lack of Public Trust

2 weeks ago talkbio0Tagged BARDA, COVID19 (disease), grant cancellation, Jay Bhattacharya, mRNA Vaccine, NIH Mouse, public trust, research funding, RFK Jr., Vaccination Hesitancy

NIH; mRNA vaccine; public trust; research funding; BARDA; COVID-19; vaccine hesitancy; RFK Jr.; Jay Bhattacharya; grant cancellation

Response Pharma: RDX-002 Limits Weight Regain After GLP-1 Therapy – Positive Phase II Results Announced

2 weeks ago talkbio0Tagged cardiometabolic health, Discontinuation (procedure), Glucagon-Like Peptide 1, iMTP, Inhibitor, Obesity, Phase 2 Clinical Trials, postprandial, RDX-002, Response process, Triglycerides, weight regain

Response Pharmaceuticals; RDX-002; GLP-1 discontinuation; weight regain; obesity; Phase II clinical trial; postprandial triglycerides; cardiometabolic health; iMTP inhibitor