Why BlueWind Medical’s latest FDA clearance matters for long-term urgency urinary incontinence care
BlueWind Medical secures FDA clearance for an enhanced Revi wearable. Find out why usability may define the next phase of neuromodulation adoption.
Medical Devices & Diagnostics
Pharma & Biotech
What Cosette Pharmaceuticals’ first generic ciprofloxacin hydrocortisone launch reveals about FDA CGT incentives
Cosette Pharmaceuticals launches the first generic ciprofloxacin hydrocortisone otic suspension. Find out what this FDA CGT approval really changes.
Pharma & Biotech
Sanofi’s tau-focused Alzheimer’s deal highlights growing confidence in non-amyloid targets
Sanofi’s $1 billion Alzheimer’s deal with ADEL highlights why tau biology is back in focus and what risks still stand between promise and proof.
Pharma & Biotech
LifeNet Health acquires Tissue Testing Technologies to scale biopreservation in regenerative medicine
LifeNet Health has announced the acquisition of Tissue Testing Technologies LLC (T3), a South Carolina–based biotechnology company specializing in advanced biopreservation. The deal expands LifeNet Health’s capabilities in organ and tissue preservation by integrating proprietary vitrification and warming technologies developed by Tissue Testing Technologies. The transaction is positioned to enhance clinical transplantation success rates, support
Medical Devices & Diagnostics
Detect-ION, Mayo Clinic join forces to develop non-invasive pneumonia breath test
Detect-ION, a diagnostics-focused startup based in Tampa, Florida, has announced a collaborative project with the Infectious Diseases Division at Mayo Clinic Florida to develop a non-invasive breath test for detecting Pseudomonas aeruginosa, a leading cause of pneumonia in vulnerable patient populations. Funded through the Mayo Clinic Advanced Innovation Research program, the project aims to address
Pharma & Biotech
Immunome’s Phase 3 varegacestat data could redefine gamma secretase inhibition in desmoid tumors
Immunome is set to release pivotal Phase 3 varegacestat data in desmoid tumors. Find out what the RINGSIDE results could change for the field.
Pharma & Biotech
Milestone Pharmaceuticals’ CARDAMYST nasal spray wins FDA approval: A new chapter for self-administered PSVT treatment
Milestone Pharmaceuticals’ CARDAMYST FDA approval marks a new era in PSVT care. Find out how this first‑in‑class nasal treatment could transform acute arrhythmia management.
Medical Devices & Diagnostics
Bioretec secures FDA Breakthrough status for RemeOs DrillPin, sharpening focus on pediatric fracture repair
Bioretec Ltd, the Finland-based medical device developer specializing in fully biodegradable orthopedic implants, has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its RemeOs DrillPin. The designation applies to the use of the biodegradable magnesium-alloy device in pediatric and adult bone fixation procedures, including epimetaphyseal fractures in children over two years
Pharma & Biotech
Vaxxas earns GMP licence for HD-MAP production—what this unlocks for clinical trials
Vaxxas Pty Ltd, the Australian biotechnology company known for its high-density microarray patch (HD-MAP) platform, has secured a manufacturing licence from the Therapeutic Goods Administration (TGA) to produce its investigational vaccine delivery system under Good Manufacturing Practice (GMP) conditions. The licence, granted for its Brisbane-based biomedical facility, clears a critical regulatory hurdle and allows Vaxxas
Pharma & Biotech
Can nivolumab plus AVD become the new frontline treatment in classical Hodgkin lymphoma?
FDA fast-tracks review of Opdivo plus AVD for first-line Hodgkin lymphoma. Find out what this immunotherapy combo could change for patients and providers.