Updated Efficacy Data of Ivonescimab Plus Chemotherapy as First-Line Treatment for TNBC at ESMO IO 2025

ivonescimab; Yidafan; PD-1/VEGF bispecific antibody; triple-negative breast cancer; TNBC; first-line treatment; ESMO IO 2025; Phase II trial; chemotherapy combination; objective response rate; progression-free survival; disease control rate; PD-L1 CPS subgroups; safety profile; Breakthrough Therapy Designation; HARMONi-BC1; AK112-308

Spotlight On: It’s Raining AI Devices as Regulatory Storm Reshapes Digital Health

AI-enabled medical devices; digital health regulation 2025; FDA AI draft guidance; EU AI Act health; generative AI in healthcare; SaMD regulation; clinical oversight of AI; AI accountability in healthcare; digital mental health devices

Biogen, Stoke Boost Epilepsy Drug’s Blockbuster Potential With Early Seizure Reduction Data

Biogen; Stoke Therapeutics; zorevunersen; Dravet syndrome; epilepsy; antisense oligonucleotide; seizure reduction; blockbuster drug; EMPEROR Phase III trial; American Epilepsy Society 2025; Jefferies analysts; natural history controls; SCN1A

Plus Therapeutics to Present ReSPECT Phase 1 Dose Escalation Data in Leptomeningeal Metastases at SABCS 2025

Plus Therapeutics; ReSPECT-LM; Phase 1; dose escalation; REYOBIQ; leptomeningeal metastases; San Antonio Breast Cancer Symposium; SABCS 2025; poster spotlight; central nervous system cancers; radiotherapeutics

Cereno Scientific Secures SEK 100m in Directed Share Issue and SEK 350m Loan Financing, Targeting Milestones by Q4 2027

Cereno Scientific; SEK 100 million; Directed share issue; SEK 350 million; Loan financing; Q4 2027 milestones; HDAC inhibitor portfolio; Pulmonary arterial hypertension; Clinical development; Rare cardiovascular diseases

Recent Developments in Medical Affairs Reputation and Hemophilia A Management in the US (2025)

Medical Affairs; Reputation; Hemophilia A; US; 2025; Gene Therapy; Public Health Policies; Hemophilia Treatment Centers; 340B Program; Federal Funding; Acquired Hemophilia A Pipeline; Healthcare Policy; CDC; HRSA

Gan & Lee Pharmaceuticals Initiates Phase 3 Clinical Study (GRADUAL-3) of the First Chinese Once-Monthly GLP-1 RA for Weight Management

Gan & Lee Pharmaceuticals; Phase 3 clinical study; GRADUAL-3; once-monthly GLP-1 RA; weight management; Chinese innovation