Immunologic Factor
Moderna’s Diversification Strategy Hindered by FDA Delay in RSV Vaccine Review
Moderna, FDA, RSV vaccine, diversification strategy, vaccine review, delay
Moderna’s RSV Vaccine Decision Postponed by FDA to Late May
FDA, Moderna, RSV vaccine, decision, delay, May
MacroGenics Reviews Safety Protocols Following Three Patient Deaths in Prostate Cancer Drug Trial
MacroGenics, Phase 2 trial, prostate cancer, patient deaths, safety review, margetuximab, bispecific antibody
Revolutionizing Public Health: CBER’s Peter Marks and the Vision to Reduce FDA Visits
CBER, Peter Marks, FDA, public health, healthcare innovation, regulatory affairs, biologics, vaccines, medical devices, preventive measures.
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.
FDA to Review Lilly’s Alzheimer’s Drug Donanemab in June Advisory Committee Meeting
FDA, Lilly, Alzheimer’s, donanemab, June, AdCom, review, approval, treatment, neurodegenerative disease.
Zenas Biotech Secures $200 Million for Advancing Obexelimab in Pivotal Immunology Trials
Zenas Biotech, obexelimab, immunology trials, funding, biotechnology, drug development, autoimmune diseases, B-cell-directed therapy.
ADC Therapeutics Showcases Promising Zynlonta Data in Marginal Zone Lymphoma and Secures $105M in Funding
ADC Therapeutics, Zynlonta, marginal zone lymphoma, share sale, funding, cancer treatment, antibody-drug conjugate, clinical trials, biotechnology, healthcare.
Pharmaceutical Industry’s Public Image Deteriorates Post-Pandemic Era
Pharmaceutical industry, reputation, pandemic, public opinion, COVID-19, vaccine development, drug pricing, transparency.
FDA Grants Full Approval to Pfizer’s Tivdak for Advanced Cervical Cancer Treatment
FDA, Pfizer, Tivdak, full approval, advanced cervical cancer, treatment, regulatory tracker