Datroway nears EU first-line approval for metastatic triple-negative breast cancer
Discover how Datroway’s EU recommendation could reshape first-line treatment for metastatic triple-negative breast cancer. Read the analysis.
Pharma & Biotech
Pharma & Biotech
Acadia Pharmaceuticals secures positive CHMP opinion for Daybu in narrowed Rett syndrome indication
Discover why Daybu’s CHMP turnaround could reshape Rett syndrome treatment in Europe and what clinical and access hurdles remain.
Pharma & Biotech
FDA approves Lumvoa for thyroid eye disease as Viridian enters commercial biotech
See how Lumvoa’s FDA approval could reshape thyroid eye disease treatment, challenge Tepezza and test Viridian’s launch strategy.
Medical Devices & Diagnostics
Thubrikar Aortic Valve expands Optimum TAVI CE Mark trial with MAC’s MEDICAL Group
See how Thubrikar Aortic Valve’s MAC’s MEDICAL deal could accelerate the Optimum TAVI System’s CE Mark path and European rollout.
Pharma & Biotech
FDA approves BESREMi Pen as PharmaEssentia targets easier long-term polycythemia vera treatment
FDA approval brings BESREMi Pen to U.S. polycythemia vera care. Find out how convenience, safety and access may shape adoption.
Pharma & Biotech
Capricor faces an FDA panel for deramiocel, but has HOPE-3 truly resolved its Duchenne evidence gap?
Capricor Therapeutics has secured a July 29 FDA advisory committee meeting for deramiocel after a positive Phase 3 trial revived the previously rejected Duchenne muscular dystrophy application. The therapy now has controlled evidence of skeletal and cardiac benefit, but regulators must still weigh endpoint interpretation, long-term external comparisons, manufacturing reliability and whether the proposed label
Medical Devices & Diagnostics
PorTal Access wins FDA clearance for FLEXI-PORT, but can a flexible chemo port change cancer care?
PorTal Access can begin commercialising its FLEXI-PORT implantable vascular access system for adults and children. Its flexible design, chest-or-arm placement options and smaller implantation profile could improve long-term infusion access, but clinical adoption will depend on complication data, hospital economics and proof that design changes produce meaningful patient benefits.
Features & Analysis
Avacta secures single-trial FDA path for AVA6000, but can its low-FAP cancer signal survive a pivotal test?
Avacta Group PLC has agreed a potential full-approval pathway for faridoxorubicin with the United States Food and Drug Administration, while new clinical analyses suggest the drug may work even in tumours with very low FAP expression. The pivotal opportunity is becoming clearer, but Avacta still needs mature progression-free survival data, a development partner and evidence
Medical Devices & Diagnostics
Aidoc’s AI can draft chest X-ray reports, but can radiologists safely trust the first read?
Aidoc has secured FDA Breakthrough Device Designation for First Read, an investigational artificial intelligence system designed to analyse chest radiographs and generate preliminary report text. The technology could reduce reporting pressure, but automation bias, missed findings and unclear liability remain significant barriers.
Pharma & Biotech
FDA gives Replimune’s RP1 a third chance, but can it overcome the same melanoma evidence gap?
The FDA has accepted Replimune’s latest RP1 resubmission and set an August 2 decision date, reviving a melanoma programme rejected twice over trial-design and efficacy questions. A late-July advisory committee will determine whether durable responses can outweigh the absence of definitive controlled evidence.