Biologics
Pharmaceuticals

Teva's TEV-408 meets primary endpoint in celiac Phase 2a

Teva's anti-IL-15 antibody TEV-408 significantly reduced gluten-induced intestinal damage versus placebo in a 50-patient Phase 2a study.
Teva's anti-IL-15 antibody TEV-408 significantly reduced gluten-induced intestinal damage versus placebo in a 50-patient Phase 2a study.
Medical Devices

Medtronic raises FY27 guidance after 13.7% Q1 revenue growth

Medtronic posted Q1 revenue of $9.8bn, beating its own guidance midpoint, and lifted its full-year organic growth outlook to 7.25–7.75%.
Medtronic posted Q1 revenue of $9.8bn, beating its own guidance midpoint, and lifted its full-year organic growth outlook to 7.25–7.75%.
Diagnostics
Pharmaceuticals
Biologics

Juniper's JBS-003 wins FDA Breakthrough Therapy Designation

The FDA granted Breakthrough Therapy Designation to JBS-003, a hypoxia tracer designed to halve radiation doses in HPV-positive head and neck cancer.
The FDA granted Breakthrough Therapy Designation to JBS-003, a hypoxia tracer designed to halve radiation doses in HPV-positive head and neck cancer.
Medical Devices
Diagnostics

Alpha Tau completes 48-patient IMPACT pancreatic cancer enrolment

Alpha Tau Medical has finished enrolling 48 patients in its IMPACT pilot study of Alpha DaRT for unresectable pancreatic cancer, with data expected in early
Alpha Tau Medical has finished enrolling 48 patients in its IMPACT pilot study of Alpha DaRT for unresectable pancreatic cancer, with data expected in early
Pharmaceuticals
Diagnostics

BioVie completes treatment phase of bezisterim Long COVID trial

BioVie says its ADDRESS-LC Phase 2 trial of bezisterim has finished dosing, with topline results expected before end of September 2026.
BioVie says its ADDRESS-LC Phase 2 trial of bezisterim has finished dosing, with topline results expected before end of September 2026.
Pharmaceuticals
Biologics

Boehringer Ingelheim launches SCOVELLA for equine laminitis in GB

Velagliflozin oral solution becomes the first licensed therapy for insulin dysregulation in horses, targeting the primary driver of laminitis.
Velagliflozin oral solution becomes the first licensed therapy for insulin dysregulation in horses, targeting the primary driver of laminitis.
Diagnostics
Medical Devices
Regulatory Science

Intelligent Bio Solutions hits 98% accuracy ahead of 510(k) filing

The Nasdaq-listed medtech said its fingerprint sweat drug screening system achieved 98.2% accuracy in a three-site study, with a 510(k) submission
The Nasdaq-listed medtech said its fingerprint sweat drug screening system achieved 98.2% accuracy in a three-site study, with a 510(k) submission
Diagnostics
Genomics
Pharmaceuticals

Kala Bio signs LOI to distribute Virotek ophthalmic genetic tests

Kala Bio will market Virotek's CLIA-registered ophthalmology genetic screening programme across U.S. eye care practices, targeting a definitive deal within 30 days.
Kala Bio will market Virotek's CLIA-registered ophthalmology genetic screening programme across U.S. eye care practices, targeting a definitive deal within 30 days.
Cell & Gene Therapy
Biologics
Regulatory Science

Ultragenyx publishes 96-week Phase 3 data for GENGLYCOS in GSDIa

Peer-reviewed results show a 61% mean reduction in daily cornstarch intake at Week 96, with glycaemic control maintained across both treatment groups.
Peer-reviewed results show a 61% mean reduction in daily cornstarch intake at Week 96, with glycaemic control maintained across both treatment groups.
Diagnostics
Pharmaceuticals

Telix completes BiPASS enrolment and aligns with FDA on NDA path

Telix has finished enrolling 350 patients in its Phase 3 pre-biopsy PSMA-PET study and confirmed an NDA pathway with the FDA that could
Telix has finished enrolling 350 patients in its Phase 3 pre-biopsy PSMA-PET study and confirmed an NDA pathway with the FDA that could
Cell & Gene Therapy
Biologics
Regulatory Science

Ocugen doses first patient in Phase 3 gene therapy trial for dry AMD

Ocugen has initiated its Phase 3 ArMaDa3 trial of OCU410 for geographic atrophy, backed by FDA RMAT designation and a BLA filing targeted for 2028.
Ocugen has initiated its Phase 3 ArMaDa3 trial of OCU410 for geographic atrophy, backed by FDA RMAT designation and a BLA filing targeted for 2028.
Biologics
Pharmaceuticals

Upstream Bio plans dual Phase 3 trials for verekitug in 2027

The Waltham biotech will start pivotal studies in severe asthma and CRSwNP in Q1 2027, targeting a quarterly 400 mg subcutaneous regimen.
The Waltham biotech will start pivotal studies in severe asthma and CRSwNP in Q1 2027, targeting a quarterly 400 mg subcutaneous regimen.
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