FDA Backs Proposed Stem Cell Trial for Treatment-Resistant Crohn’s Disease
StemSmart Crohn’s disease clinical trial gets positive FDA pre-IND feedback on 6 of 7 questions; a viral safety issue remains. Not a marketing approval.
FDA Backs Proposed Stem Cell Trial for Treatment-Resistant Crohn’s Disease
StemSmart Crohn’s disease clinical trial gets positive FDA pre-IND feedback on 6 of 7 questions; a viral safety issue remains. Not a marketing approval.
Lasix ONYU Home Study: 18 of 21 Heart Failure Patients Avoided Admission
Early data say 18 of 21 heart failure patients were treated at home with Lasix ONYU. What hospital leaders can and cannot conclude from a single-arm study.
Castle Biosciences Data Show Barrett’s Risk Test Shifts Surveillance Plans
Castle Biosciences says TissueCypher changed Barrett’s management for 96% of cohort patients. Where the test fits in surveillance and what is unproven.
Envoy’s Fully Implanted Cochlear Implant Files Second FDA Module
Envoy Medical has filed 2 of 4 FDA modules for its investigational Acclaim implant. A status board of what is done, pending and still undisclosed.
Sun Pharma Board Caps Debenture Raise at ₹10,000 Crore
Sun Pharma will raise up to ₹10,000 crore via NCDs, down from ₹15,000 crore, as Gautam Doshi quits. NCD terms explained, ratings and open questions.
Tortugas’ Obuprazine Beats Placebo in Phase 2b Schizophrenia Study
Tortugas reports obuprazine beat placebo at all doses in a 363-patient Phase 2b. Five claims checked against the evidence, plus what is still missing.
Supreme Court Pushes Beyond Cancer Drugs on Medicine Prices
Judges asked why India’s 30% cancer drug margin cap should not cover other medicines. What changes for makers, chemists, hospitals and patients.
Stryker Invests $400M in CMR Surgical: What the Deal Covers
Stryker commits about $400M to CMR Surgical, gains US Versius sales rights and a buy-out option. Answers on terms, risks and what is still undisclosed.
FDA Early Alert: Philips Lumify Ultrasound Issue, Four Deaths Reported
Philips Lumify ultrasound FDA safety alert: four deaths and eight serious injuries reported over two faults. What the FDA said and what users should do.
