Safety
FDA Halts BioNTech-MediLink ADC Trial Due to ‘Significant Risk of Illness or Injuries’
FDA, BioNTech, MediLink, ADC, Clinical Trial, Safety Concerns, Cancer Treatment
PTC Therapeutics Reports Positive Phase II Huntington’s Disease Data, FDA Lifts Partial Clinical Hold
PTC Therapeutics, Huntington’s disease, Phase II data, FDA, partial clinical hold, PTC518, mutant huntingtin protein, clinical trends, safety, tolerability.
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.