Human-caused Phenomenon or Process
Gilead’s Magrolimab Ineffective, Linked to Increased Risk of Death in MDS Patients
Gilead, Magrolimab, MDS, Myelodysplastic Syndrome, Cancer Treatment, Clinical Trials, Safety Concerns
Bulevirtide: A Novel Treatment for Chronic Hepatitis Delta Virus Infection
Bulevirtide, Hepatitis Delta Virus (HDV), Chronic Infection, Antiviral Therapy, Clinical Trials, Efficacy, Safety
Miniature Swine: Revolutionizing Nonclinical Studies for Small Molecules and Biologics
Miniature swine, Nonclinical studies, Small molecules, Biologics, Dermal testing, Safety assessments, Research models
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.