Why ImmunityBio’s Japan BCG Laboratory agreement matters beyond bladder cancer supply
A bladder cancer supply crisis meets fresh Phase III data. ImmunityBio’s Tokyo BCG deal could test how flexible U.S. regulators are willing to be.
Pharma & Biotech
Pharma & Biotech
Dr. Reddy’s moves first in Canada’s generic semaglutide market. Can access improve?
GLP-1 demand is booming, but access remains uneven. Dr. Reddy’s Canada launch tests whether generics can change semaglutide economics.
Pharma & Biotech
ENHERTU enters curative-intent breast cancer care as FDA widens AstraZeneca and Daiichi Sankyo label
ENHERTU is moving earlier in breast cancer care. The bigger question is whether efficacy gains can outweigh ADC safety scrutiny.
Pharma & Biotech
Can United Therapeutics turn pig-heart xenotransplantation into a regulated clinical pathway?
A pig-heart trial is no longer just a scientific leap. United Therapeutics now faces the harder test of safety, scale, and regulation.
Features & Analysis
Can non-viral gene therapies solve the safety problem holding back genetic medicine?
Viral vectors built gene therapy’s first era. Safety, redosing and manufacturing pressure are pushing non-viral platforms into the spotlight.
Features & Analysis
Why clinical biomarkers face a slow climb before regulators accept them as surrogate endpoints
Biomarkers can speed drug approvals, but weak validation can haunt sponsors. FDA and EMA are tightening the path from signal to endpoint.
Pharma & Biotech
AstraZeneca’s Imfinzi becomes first NHS immunotherapy for operable stomach cancer
Stomach cancer care gains immunotherapy, but NHS adoption now depends on surgery timing, toxicity management and recurrence data.
Pharma & Biotech
What Kyowa Kirin’s Crysvita dosing change reveals about rare disease treatment individualisation
Rare disease dosing is becoming more personalised. Kyowa Kirin’s Crysvita update tests how far flexibility can improve adult XLH care.
Medical Devices & Diagnostics
Why BlueWind Medical’s $47.8m raise matters for the next phase of UUI treatment
UUI devices have clinical momentum. BlueWind Medical’s next challenge is proving Revi can scale through access, reimbursement, and workflow adoption.
Medical Devices & Diagnostics
Is Butterfly Medical’s prostate retraction device the next challenger in minimally invasive BPH treatment?
BPH care needs options beyond pills and surgery. Butterfly Medical’s $21m raise puts its reversible prostate implant in the spotlight.