CHMP Rejects Sanofi’s Rezurock Over Clinical Data Issues, Recommends Approval of BTK Inhibitor Wayrilz
Sanofi; CHMP; EMA; Rezurock; Wayrilz; Belumosudil; Rilzabrutinib; chronic graft-versus-host disease; cGVHD; immune thrombocytopenia; ITP; regulatory approval; clinical data
FDA Announces First Recipients of Makary’s National Priority Voucher Program, Expanding Scope for Accelerated Drug Reviews
FDA; National Priority Voucher; CNPV; Martin Makary; priority review; accelerated drug approval; 2025 pilot program; voucher recipients; public health crisis; domestic drug manufacturing
Recent Advances and News in In Vivo Therapeutic Technologies (2025)
in vivo CAR-T; cell therapy; gene therapy; RNA delivery; autoimmune disease; oncology; nanoparticle delivery; drug delivery innovation; FDA fast track; biotech acquisitions
EMD Serono Joins TrumpRx in Affordability Push; Roche Launches DTC Program
EMD Serono; TrumpRx; IVF therapies; affordability; fertility drugs; Direct-to-Consumer sales; Roche; DTC program; White House Executive Order; Section 232 tariffs; CNPV program; Pergoveris
Connecticut Biotech Veradermics Secures $150M for Phase 3 Trials of Oral Rogaine
Veradermics; Connecticut biotech; oral Rogaine; Phase 3 clinical trials; fundraising; hair loss treatment; biotechnology; clinical development
White House Announces New Most-Favored Nation Drug Pricing Deal, Updates on FDA Vouchers and GLP-1 Negotiations
most-favored nation pricing; fertility drugs; IVF; Trump administration; drug pricing; Medicaid; FDA vouchers; GLP-1; EMD Serono; Pfizer; AstraZeneca
Praxis Precision Medicines, Inc. Announces Pricing of $525 Million Public Offering
Praxis Precision Medicines; public offering; $525 million; stock offering; share offering; pricing; biopharmaceutical; central nervous system disorders
Friday Five: ESMO Looms Large, Arcus’ TIGIT Revival, and J&J’s Myeloma Advances
ESMO 2025; Arcus Biosciences; domvanalimab; TIGIT antibody; gastroesophageal adenocarcinoma; J&J; multiple myeloma; immuno-oncology; PD-1 inhibitor; zimberelimab; oncology clinical trials
Sanofi Partners with EVOQ Therapeutics to Advance NanoDisc-Based Autoimmune Therapies
Sanofi; EVOQ Therapeutics; NanoDisc; autoimmune disease; license agreement; immune tolerance; celiac disease; type 1 diabetes; MOG antibody disease; rheumatoid arthritis; lupus
Merck & Co. Announces Keytruda Achieves First Overall Survival Benefit in Resistant Ovarian Cancer
Merck & Co.; Keytruda; pembrolizumab; ovarian cancer; platinum-resistant; overall survival; checkpoint inhibitor; KEYNOTE-B96 trial; progression-free survival; PD-L1