Injury or Poisoning

ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use

3 weeks ago talkbio0Tagged ARC-EX System, CE Mark, Clearance, hand sensation, Hand Strength, Home Use, Medical Devices, Medical service, neurotechnology, ONWARD, Spinal Cord Injuries, United States Food and Drug Administration

ONWARD Medical; FDA 510(k) clearance; ARC-EX System; home use; spinal cord injury; hand strength; hand sensation; neurotechnology; CE Mark; medical device

Intercept Withdraws Ocaliva from US Market After FDA Safety Concerns

3 months ago talkbio0Tagged Clinical Trials, concerns, Drug withdrawal syndrome, Injury of liver, Intercept Pharmaceuticals, Liver diseases, Ocaliva, Primary Biliary Cholangitis, regulatory setbacks, Safety, United States Food and Drug Administration

Intercept Pharmaceuticals; Ocaliva; liver disease; primary biliary cholangitis; FDA; drug withdrawal; safety concerns; liver injury; clinical trial hold; regulatory setbacks

CDC Launches ‘Free Mind’ Campaign Targeting Teen Substance Use and Mental Health

4 months ago talkbio0Tagged Adolescence, Alcohol or Other Drugs use, Centers for Disease Control and Prevention (U.S.), Drug Overdose, fentanyl, Free Mind ' Campaign, mental health, Strategy, teen suicide

CDC; Free Mind campaign; youth mental health; substance use; drug overdose; fentanyl; teen suicide; coping strategies

Elevidys Sales Surge in Sarepta Q2 2025 Despite Safety Concerns

4 months ago talkbio0Tagged ELEVIDYS, gene therapy, Pauses, Performance, Safety Issues, Sales - occupational activity, United States Food and Drug Administration

Sarepta Therapeutics; Elevidys; Q2 2025; gene therapy; sales performance; FDA; safety issues; shipment pause

Pfizer’s Embattled Obesity Program Loses Another GLP-1 Drug Due to Data and Competition Issues

4 months ago talkbio0Tagged Agonist, Clinical Trials, competition, Danuglipron, Drug Development, Glucagon-Like Peptide 1, Injury of liver, lotiglipron, Obesity, PF-06954522, Pfizer

Pfizer; obesity; GLP-1 agonist; clinical trial; liver injury; danuglipron; lotiglipron; PF-06954522; obesity drug development; competition

FDA Delays Blenrep Decision, Challenging GSK’s Multiple Myeloma Comeback Plans

5 months ago talkbio0Tagged Blenrep, Deferred, Multiple Myeloma, Neoplasms, Ocular Toxicity, PDUFA, regulatory hurdles, SmithKline Beecham, United States Food and Drug Administration

FDA delay; Blenrep; GSK; multiple myeloma; regulatory hurdles; ocular toxicity; PDUFA; oncology; relapsed/refractory

FDA Advisory Panel Rejects GSK’s Blenrep in New Combinations Over Safety, Efficacy Concerns

5 months ago talkbio0Tagged Advisory Panel, Blenrep, concerns, DREAMM, Drug Approval, Multiple Myeloma, Ocular Toxicity, Refractory Plasma Cell Myeloma, Relapsing course, Safety, SmithKline Beecham, trials, United States Food and Drug Administration

Blenrep; GSK; FDA Advisory Panel; multiple myeloma; ocular toxicity; safety concerns; DREAMM trials; drug approval; relapsed or refractory multiple myeloma

Pfizer’s Strategic Shift Post-Danuglipron: Exploring New Frontiers in Obesity Treatment

8 months ago talkbio0Tagged Danuglipron, GLP-1 receptor, GLP-1/GIP therapies, Injury of liver, Metabolic Diseases, Obesity, Pfizer, Pharmaceutical competition, pipeline, Weight-Loss Agents

Pfizer, danuglipron, obesity treatment, GLP-1 receptor agonist, liver injury, weight-loss drugs, GLP-1/GIP therapies, pharmaceutical competition, metabolic diseases, Viking Therapeutics, obesity pipeline