Alkermes launches 180-patient Phase 2 ALKS 7290 trial testing orexin activation in major depression
Alkermes starts a 180-patient Phase 2 ALKS 7290 depression trial, testing orexin activation alongside antidepressants and assessing safety.
Pharma & Biotech
Pharma & Biotech
Forlong Biotechnology doses first patient in Australian Phase 1 trial of subcutaneous FL115
Forlong Biotechnology begins Australian Phase 1 testing of subcutaneous FL115, targeting lower peak exposure and improved immune activation.
Medical Devices & Diagnostics
Powerful Medical secures CPT code 1139T for Queen of Hearts AI ECG after FDA authorisation
Powerful Medical secures CPT code 1139T for Queen of Hearts AI ECG, opening a US billing pathway while reimbursement remains unresolved.
Pharma & Biotech
Japan clears IMCIVREE for acquired hypothalamic obesity as Rhythm Pharmaceuticals expands global reach
Japan approves IMCIVREE for acquired hypothalamic obesity, expanding Rhythm Pharmaceuticals’ global franchise. See what the approval means for growth.
Pharma & Biotech
Can Massive Bio and GELL turn Latin America’s lymphoma research gaps into an AI-powered clinical trial advantage?
Massive Bio and GELL unite on oncology research, education and AI, but execution will determine whether the alliance expands trial access.
Pharma & Biotech
MannKind Corporation wins FDA approval for 10-second Furoscix ReadyFlow furosemide autoinjector
FDA approves MannKind Corporation’s Furoscix ReadyFlow for heart failure and CKD edema. See how the 10-second autoinjector may change care.
Pharma & Biotech
Incannex Healthcare begins DReAMzz screening to refine IHL-42X dosing before Phase 3 sleep apnea trial
Incannex Healthcare begins DReAMzz screening to select an IHL-42X dose before Phase 3. Read what the sleep apnea study must prove.
Pharma & Biotech
Inhibikase Therapeutics gains FDA orphan status for IKT-001 as pivotal PAH trial advances
Inhibikase Therapeutics wins FDA orphan status for IKT-001 as its pivotal PAH trial tests whether a prodrug can improve imatinib tolerability.
Medical Devices & Diagnostics
No battery, no pill, no sensor: Why ANF Care’s unusual wearable is entering the United States
ANF Care is taking BioCoherence wearable discs to the United States, where evidence, claims and launch execution will shape adoption.
Medical Devices & Diagnostics
Resmed agrees $490m MatrixCare sale to Frazier Healthcare Partners
ResMed Inc. has agreed to sell its MatrixCare healthcare software business to Frazier Healthcare Partners for $490 million in cash, reversing part of a diversification strategy that began when the medical-device company acquired MatrixCare for $750 million in 2018. The transaction is expected to close during the first quarter of Resmed’s fiscal year 2027, subject