Temporal Concept
CDC Launches ‘Free Mind’ Campaign Targeting Teen Substance Use and Mental Health
CDC; Free Mind campaign; youth mental health; substance use; drug overdose; fentanyl; teen suicide; coping strategies
Elevidys Sales Surge in Sarepta Q2 2025 Despite Safety Concerns
Sarepta Therapeutics; Elevidys; Q2 2025; gene therapy; sales performance; FDA; safety issues; shipment pause
Y-mAbs Therapeutics Acquired by SERB Pharmaceuticals in $412 Million Buyout Following Strategic Review
Y-mAbs Therapeutics; SERB Pharmaceuticals; buyout; Danyelza; rare oncology; merger; pharmaceutical acquisition; strategic review; all-cash tender offer
Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay
Regeneron; Eylea HD; CRL; FDA; PDUFA; supplemental Biologics License Application; dosing intervals; retinal diseases
ImmuneOnco and Instil Bio’s PD-L1xVEGF Bispecific Antibody Shows Promising Results in Phase 2 Lung Cancer Trial
ImmuneOnco; Instil Bio; IMM2510/AXN-2510; PD-L1xVEGF bispecific antibody; NSCLC; Phase 2 clinical trial; response rate; safety profile; chemotherapy combination; lung cancer
FDA Reverses Course, Allows Sarepta to Resume Duchenne Gene Therapy Shipments
FDA; Sarepta Therapeutics; Duchenne muscular dystrophy; Elevidys; gene therapy; safety pause; shipment resumption
Roche Doubles Down on Alzheimer’s with Next-Gen Amyloid-Lowering Drug Trontinemab
Roche; Alzheimer’s disease; trontinemab; amyloid-lowering drug; Brainshuttle; Phase III trial; TRONTIER studies; drug development; biomarkers; early intervention
FDA Official Says Sarepta Faces Major Hurdles to Reintroduce DMD Therapy Elevidys
Sarepta; Elevidys; FDA; Duchenne muscular dystrophy; gene therapy; CBER; safety concerns; shipment pause; new studies; approval status
FDA Delays Blenrep Decision, Challenging GSK’s Multiple Myeloma Comeback Plans
FDA delay; Blenrep; GSK; multiple myeloma; regulatory hurdles; ocular toxicity; PDUFA; oncology; relapsed/refractory
Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys
Sarepta Therapeutics; FDA; Elevidys; Duchenne muscular dystrophy; gene therapy; shipment pause; patient deaths; safety concerns