Immunologic Factor
FDA Rejects Hepatitis B Vaccine Update Due to Inadequate Documentation and Data
FDA, hepatitis B vaccine, vaccine update, document destruction, insufficient data, rejection
Eisai and Biogen Overcome Filing Hitch, Initiate FDA Submission for Subcutaneous Leqembi
Eisai, Biogen, FDA submission, Leqembi, subcutaneous, Alzheimer’s disease, rolling submission, BLA, clinical trials, monoclonal antibody, amyloid beta, neurodegenerative disorder
FDA Rejects Dynavax’s Heplisav-B Expansion Due to Data Gaps
FDA, Dynavax, Heplisav-B, data gaps, rejection, expansion, vaccine, hepatitis B
Novel Monthly Hemophilia A Treatment by Novos Poses Challenge to Roche’s Hemlibra
Hemophilia A, Novos, Roche, Hemlibra, monthly treatment, performance, challenge.
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.