Effectiveness – Page 5

Controversy Surrounds FDA’s Fast-Track Approval of Sarepta’s Duchenne Muscular Dystrophy Gene Therapy

12 months ago talkbio0Tagged Accelerated, Advocacy, Approved, Clinical Trials, DMD, Duchenne, Effectiveness, gene therapy, Muscular Dystrophy, Muscular Dystrophy, Duchenne, Regulation of biological process, Safety, United States Food and Drug Administration

FDA, Sarepta Therapeutics, Duchenne Muscular Dystrophy (DMD), gene therapy, accelerated approval, controversy, clinical trials, efficacy, safety, patient advocacy, regulatory process.

Barinthus’ HPV Therapy Demonstrates Safety Yet Falls Short in Efficacy

1 year ago talkbio0Tagged Barinthus, Clinical Trials, Effectiveness, Homo sapiens, HPV therapy, Safety, vaccine alternatives

Barinthus, HPV therapy, safety, efficacy, clinical trials, human papillomavirus, vaccine alternatives

Barinthus Bio’s HPV Immunotherapy Fails to Demonstrate Statistically Significant Efficacy in Early Study

1 year ago talkbio0Tagged Barinthus, Bio, Effectiveness, HPV immunotherapy, underwhelming, VTP-200

Barinthus Bio, HPV immunotherapy, VTP-200, early study, underwhelming results, efficacy

Sanofi Restructures US Commercial Vaccine Group Amid Cost-Saving Campaign

1 year ago talkbio0Tagged Commercial Vaccine, Cost-Savings Campaign, Effectiveness, Efficiency, Employee, Evolving, Market, Optimization, Outplacement, restructuring, sanofi, streamlined strategic sales, Structure, Vaccines

Sanofi, Restructuring, US Commercial Vaccine Group, Cost-Savings Campaign, Streamlined Strategic Sales Structure, Evolving Vaccine Market, Optimization for Efficiency and Effectiveness, Employee Support and Outplacement Assistance

FDA Approves Vadadustat (Vafseo) for Anemia in Chronic Kidney Disease Patients on Dialysis and Daprodustat (Jesduvroq) for Dialysis-Dependent CKD Adults

1 year ago talkbio0Tagged Anemia, Approved, Black Box Warning, Chronic Kidney Diseases, Daprodustat, Effectiveness, Hemoglobin concentration result, Jesduvroq, Oral Medication, post-marketing safety, Safety, United States Food and Drug Administration, vadadustat, Vafseo

Anemia, Chronic Kidney Disease (CKD), Vadadustat (Vafseo), Daprodustat (Jesduvroq), Oral medication, FDA approval, Hemoglobin levels, Black Box Warning, Efficacy and safety data, Post-marketing safety data

FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review

1 year ago talkbio0Tagged Accelerated Approval, Aduhelm, Anticipated, Approved, aspects of adverse effects, Central Nervous System Agents, Cerebral Edema, Clinical Trials, Deferred, Donanemab, Effectiveness, eli lilly, Full approval, Hemorrhage, Leqembi, PCNS, Peripheral, precedent, Review [Publication Type], Safety, United States Food and Drug Administration

Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.