Dyne Therapeutics Reports Positive Results for Duchenne Drug DYNE-251, Plans FDA Approval Submission

Dyne Therapeutics; DYNE-251; Duchenne muscular dystrophy; exon 51 skipping; DELIVER trial; FDA Breakthrough Therapy Designation; Biologics License Application; accelerated approval

Wave Life Sciences RNA obesity shot shows fat loss with muscle preservation but trails Eli Lilly’s candidates

Wave Life Sciences; WVE-007; INHBE; RNA obesity drug; obesity shot; fat loss; muscle preservation; Eli Lilly; ADA Scientific Sessions

GSK walks away from remaining IDEAYA programs, formally ending partnership

GSK; IDEAYA Biosciences; synthetic lethality; collaboration termination; Werner helicase; Pol Theta; DNA damage repair; oncology partnership; license agreement; drug development pipeline

BioNTech and Bristol Myers Squibb Present First Global Phase 2 Data for PD-L1xVEGF-A Bispecific Antibody Pumitamig in Advanced Triple-Negative Breast Cancer

BioNTech; Bristol Myers Squibb; pumitamig; BNT327; PD-L1xVEGF-A bispecific antibody; Phase 2 trial; triple-negative breast cancer; TNBC; confirmed ORR; disease control rate; progression-free survival; PD-L1 expression; ROSETTA BREAST-01; SABCS

Bruker Adds Diagnostics Leader Jack Phillips to Board of Directors Effective January 2026

Bruker Corporation; Jack Phillips; Board of Directors; appointment; January 1 2026; diagnostics industry; corporate governance; Accelerate Diagnostics; Roche Diagnostics North America; Ventana Medical Systems

FDA Signals Higher Efficacy Bar for New CAR‑T Cancer Therapies

FDA; CAR-T; chimeric antigen receptor T-cell therapy; oncology; regulatory standards; superiority trials; randomized controlled trials; overall survival; hematologic malignancies; cell and gene therapy

Strategic solutions for cost, time and quality challenges in drug development – recent developments

drug development; cost reduction; timeline acceleration; quality management; integrated CDMO/CRO models; AI in pharma; CMC optimization; clinical development efficiency; supply chain risk; biotech strategy