Safety
GSK’s Novel Long-Acting Asthma Treatment Shows Promising Results in Phase 3 Trials
GSK, asthma treatment, Phase 3 studies, long-acting, clinical trials, efficacy, safety, respiratory disease
Tremfya Phase III Maintenance Study Results Presented by J&J for Ulcerative Colitis Treatment
J&J, Johnson & Johnson, Tremfya, guselkumab, Phase III trial, maintenance study, ulcerative colitis, inflammatory bowel disease, treatment, efficacy, safety, remission.
EMA Recommends Halt on Preterm Birth Medications Due to Safety Concerns
European Medicines Agency (EMA), safety committee, preterm birth drugs, suspension, safety concerns, pregnancy, fetal development.
AstraZeneca’s Next-Generation Covid Therapy Shines in Phase 3 Trials
AstraZeneca, Covid-19, Evusheld, Phase 3 trials, next-generation therapy, successor, antibody treatment, prevention, efficacy, safety.
Europe Temporarily Halts AstraZeneca’s Vaxzevria COVID-19 Vaccine on Company’s Request
AstraZeneca, Vaxzevria, COVID-19 vaccine, marketing authorization, suspension, Europe, European Medicines Agency (EMA), pharmacovigilance, safety concerns.
Pfizer Temporarily Suspends Dosing in Advanced Duchenne Muscular Dystrophy (DMD) Trial After Patient Fatality
Pfizer, Duchenne Muscular Dystrophy (DMD), clinical trial, dosing halt, patient death, late-stage study, temporary suspension, safety concerns, investigation.
Controversy Surrounds FDA’s Fast-Track Approval of Sarepta’s Duchenne Muscular Dystrophy Gene Therapy
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
Barinthus, HPV therapy, safety, efficacy, clinical trials, human papillomavirus, vaccine alternatives
FDA Approves Vadadustat (Vafseo) for Anemia in Chronic Kidney Disease Patients on Dialysis and Daprodustat (Jesduvroq) for Dialysis-Dependent CKD Adults
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
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.