Scholar Rock finally won FDA approval. Why did SRRK stock fall 6% when ISEMBYLD launched?
Scholar Rock starts its ISEMBYLD SMA launch after FDA approval, but SRRK falls as investors weigh a roughly $310,000 annual price and execution.
Pharma & Biotech
Pharma & Biotech
What do Definium Therapeutics’ Panorama results mean for DT120 FDA approval?
Definium’s DT120 delivers another positive Phase 3 anxiety result, putting the FDA filing and commercialization strategy firmly in focus.
Pharma & Biotech
Antibiotics are not always enough for Staph bloodstream infections. Can Armata turn bacteriophages into an FDA-approved adjunct?
FDA grants Breakthrough Therapy status to Armata’s AP-SA02 after randomized data support bacteriophage therapy in complicated Staph bacteremia.
Medical Devices & Diagnostics
Telix Pharmaceuticals wins FDA approval for PIXCLARA glioma imaging
FDA approves Telix Pharmaceuticals’ PIXCLARA, the first FET-PET drug for differentiating glioma progression from treatment-related change.
Pharma & Biotech
Full-Life wants to carry actinium-225 directly to c-MET tumors. Can FL-261 widen targeted alpha therapy beyond prostate cancer?
FDA clears Full-Life’s actinium-225 FL-261 for Phase 1 testing in c-MET-positive lung cancer as the radiopharmaceutical company expands its pipeline.
Features & Analysis
Electrophysiologists already have mapping and ultrasound. Why does LUMA Vision think they need VERAFEYE?
LUMA Vision has secured another FDA clearance expanding VERAFEYE ahead of a planned early-2027 United States launch. The system combines intracardiac ultrasound, live 3D anatomical reconstruction, catheter tracking and ablation guidance, challenging the electrophysiology lab’s traditional reliance on several separate imaging and navigation tools.
Features & Analysis
A robot can now draw blood without hands-on intervention. Can Vitestro’s Aletta solve the phlebotomy staffing problem?
Vitestro’s Aletta has become the first standalone autonomous robotic blood-draw device authorized by the FDA. With one trained supervisor permitted to oversee as many as three systems, the technology could address workforce constraints and standardize venipuncture, but throughput, cost, difficult-vein performance and patient acceptance will determine whether robotics actually changes laboratory medicine.
Features & Analysis
UCB’s CIMZIA breakthrough designation targets the placenta, not the clot. Is that the key to high-risk APS pregnancy?
The FDA has granted Breakthrough Therapy Designation to UCB’s CIMZIA for high-risk pregnant women with antiphospholipid syndrome after Phase 2 evidence suggested that adding TNF inhibition to standard aspirin and heparin could reduce severe placenta-mediated complications. The programme challenges a long-standing assumption that preventing thrombosis alone is sufficient to manage obstetric APS.
Features & Analysis
Revolution Medicines cut the risk of death by 60% with daraxonrasib. How far can the RAS platform expand?
Revolution Medicines’ RASONQUE has become the first broad RAS-targeted therapy approved for metastatic pancreatic adenocarcinoma after Phase 3 data showed a 60% reduction in the risk of death compared with chemotherapy. The approval matters well beyond one cancer because it tests whether RAS, long regarded as one of oncology’s hardest targets, can support an entire
Features & Analysis
AstraZeneca’s Etcamah worked when an ESR1 mutation appeared. Why did the broader first-line trial fail?
AstraZeneca has secured FDA accelerated approval for Etcamah after SERENA-6 showed that switching therapy when an ESR1 mutation emerged in circulating tumour DNA sharply delayed disease progression. Days later, however, the broader SERENA-4 first-line trial missed its primary endpoint, creating an unusually clear demonstration that patient selection and treatment timing may matter as much as