FDA Advisory Panel Rejects GSK’s Blenrep in New Combinations Over Safety, Efficacy Concerns

Blenrep; GSK; FDA Advisory Panel; multiple myeloma; ocular toxicity; safety concerns; DREAMM trials; drug approval; relapsed or refractory multiple myeloma

Sarepta Shifts Focus to siRNA Platform, Lays Off 500 After Elevidys Receives Black Box Warning

Sarepta Therapeutics; siRNA platform; Elevidys; Duchenne muscular dystrophy; layoffs; black box warning; pipeline shift; acute liver injury; gene therapy; restructuring

AstraZeneca Amyloidosis Drug Fails Phase 3 Trials but Shows Potential in Subgroup

AstraZeneca; amyloidosis; anselamimab; Phase 3 trial; clinical trial failure; prespecified subgroup; rare diseases; Alexion; AL amyloidosis; drug development

FDA Flags Eye Safety Concerns as GSK Seeks Blenrep’s US Return

GSK; Blenrep; FDA; eye safety; ocular toxicity; advisory committee; multiple myeloma; drug approval; United States; relapsed/refractory multiple myeloma

LEO Pharma Acquires Exclusive Global Rights for Boehringer Ingelheim’s Psoriasis Drug Spevigo in €90 Million Deal

LEO Pharma; Boehringer Ingelheim; Spevigo; spesolimab; psoriasis; GPP; drug licensing; immunology; IL-36 receptor; partnership; biotech news