Safety – Talk Bio

FDA Commissioner Makary Addresses COVID-19 Vaccine Safety Concerns Amid Internal Debates and Investigations

4 weeks ago talkbio0Tagged Cautionary Warning, COVID19 (disease), Marty Makary, mRNA Vaccines, Myocarditis, RFK gene, Safety, United States Food and Drug Administration, vaccine deaths, Vaccines

Marty Makary; FDA; COVID-19 vaccine; myocarditis; vaccine deaths; safety warnings; RFK Jr.; mRNA vaccines

ADC Therapeutics to Provide Update on LOTIS-7 Clinical Trial on December 3, 2025

1 month ago talkbio0Tagged clinical trial update, Corporate, Effectiveness, loncastuximab tesirine, LOTIS-7, Phase 1b Trial, Safety, therapeutic autologous dendritic cells, Zynlonta

ADC Therapeutics; LOTIS-7; clinical trial update; ZYNLONTA; Phase 1b trial; loncastuximab tesirine; safety; efficacy; corporate webcast

AI-Designed Drug AH-001 Completes U.S. Phase I Trial, Demonstrating Excellent Safety and Tolerability

2 months ago talkbio0Tagged AH 001, AI-designed drug, Alopecia, Androgenetic Alopecia, AnHorn Medicines, Generative AI, Phase I Clinical Trials, protein degrader, Safety, tolerability

AH-001; AI-designed drug; Phase I clinical trial; safety; tolerability; androgenetic alopecia; protein degrader; AnHorn Medicines; generative AI; hair loss

Intellia Pauses Two CRISPR Trials After Severe Liver Toxicity Hospitalizes Patient

3 months ago talkbio0Tagged Clustered Regularly Interspaced Short Palindromic Repeats, Gene Modification, Hospitalization, Intellia, Liver, Pauses, Phase 3 Clinical Trials, Safety, Senile cardiac amyloidosis, Toxicity aspects

Intellia Therapeutics; CRISPR; transthyretin amyloidosis; Phase III trials; gene editing; liver toxicity; patient hospitalization; safety pause

Halda’s HLD-0915 Shows Promising First-in-Human Results as a Safer RIPTAC Cancer Therapeutic

3 months ago talkbio0Tagged anti-tumor activity, first-in-human, Halda Therapeutics, HLD-0915, Metastatic castration-resistant prostate cancer, Oral cavity, RIPTAC, Safety

Halda Therapeutics; HLD-0915; RIPTAC; metastatic castration-resistant prostate cancer; first-in-human; safety; anti-tumor activity; oral therapeutic

Lilly’s Oral GLP-1, Orforglipron, Achieves Two New Clinical Wins in Type 2 Diabetes

3 months ago talkbio0Tagged ACHIEVE-1, ATTAIN-2, Clinical Trials, Diabetes Mellitus, Non-Insulin-Dependent, Effectiveness, Eli Lilly, Farxiga, Glucagon-Like Peptide 1, Oral cavity, orforglipron, regulatory submission, Safety, semaglutide, Weight Loss

Lilly; Orforglipron; oral GLP-1; type 2 diabetes; clinical trial; weight loss; regulatory submission; ACHIEVE-1; ATTAIN-2; semaglutide; Farxiga; efficacy; safety

Intercept Withdraws Ocaliva from US Market After FDA Safety Concerns

4 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