Review [Publication Type]
Biopharma’s Winners and Losers of 2025 – Endpoints News recap
Endpoints News; winners and losers; 2025; biopharma; Post-Hoc Live; Kyle LaHucik; year in review; biotech; pharma; stock movers
Sanofi’s multiple sclerosis drug tolebrutinib flunks Phase 3 in PPMS and faces another FDA PDUFA delay
Sanofi; tolebrutinib; multiple sclerosis; primary progressive multiple sclerosis; PPMS; non-relapsing secondary progressive MS; nrSPMS; Phase 3 PERSEUS trial; PDUFA delay; FDA review; BTK inhibitor; clinical trial failure; regulatory setback
FDA Launches New Priority Review Voucher Program Aligned with National Priorities
FDA; priority review voucher; CNPV; biopharma; drug approval; national priorities; accelerated review; unmet public health needs
Capricor shares turn red as FDA plans deramiocel adcomm, likely the first under new commissioner
United States Food and Drug Administration, Capricor, deramiocel, Market, Review [Publication Type], Biologics License Application, first
FDA official said to step in and pause review of Novavax’s COVID-19 vaccine
United States Food and Drug Administration, COVID19 (disease), Vaccines, Novavax ‘s, Review [Publication Type], Novavax, Approved
Moderna CEO Reflects on 2024 Challenges and Advances in Shareholder Letter
Moderna, shareholder letter, 2024 review, RSV vaccine, COVID-19 vaccine, mRNA medicines, Stéphane Bancel
Dupixent (Dupilumab) Advances Towards FDA Approval for Chronic Spontaneous Urticaria (CSU) in 2025
Dupixent, Dupilumab, Chronic Spontaneous Urticaria (CSU), FDA Review, Sanofi, Regeneron, Biologic Medicine, Type 2 Inflammation, H1 Antihistamines
UK Regulator Approves Pharming’s Joenja for Rare Immune Disorder APDS, Leveraging FDA Review
Joenja, leniolisib, APDS, MHRA approval, FDA review, rare immune disorder, Pharming
Ascendis Hormone Replacement Therapy Faces Setback with FDA Review Extension
Ascendis Pharma, hormone replacement therapy, FDA review, delay, three-month extension.
Extended FDA Review Timeline for Ascendis’ Hormone Therapy
Ascendis Pharma, hormone therapy, FDA review, delay, 3 months extension.