Regulatory Science
Biotech

Avalyn Pharma to present AP01 usability and IPF patient data at ATS 2026

Avalyn will show poster data on inhaled pirfenidone nebuliser usability and patient-centred supportive care in pulmonary fibrosis at ATS in Orlando.
Avalyn will show poster data on inhaled pirfenidone nebuliser usability and patient-centred supportive care in pulmonary fibrosis at ATS in Orlando.
Regulatory Science
Biotech

BridgeBio wins ANVISA approval for acoramidis in ATTR-CM

BEYONTTRA becomes the first near-complete TTR stabiliser approved in Brazil, backed by Phase 3 data showing a 42% cut in cardiovascular mortality and hospitalisation.
BEYONTTRA becomes the first near-complete TTR stabiliser approved in Brazil, backed by Phase 3 data showing a 42% cut in cardiovascular mortality and hospitalisation.
Medical Devices
Biotech

Bioventus posts 7% Q1 revenue rise and raises 2026 earnings guidance

The Durham-based medical-technology company reported Q1 net sales of $132.1m and lifted its full-year adjusted EPS and cash-flow forecasts.
The Durham-based medical-technology company reported Q1 net sales of $132.1m and lifted its full-year adjusted EPS and cash-flow forecasts.
Regulatory Science

Bioxodes reports positive Phase 2a data for BIOX-101 in ICH

Bioxodes presented final BIRCH trial data at ESOC 2026, showing BIOX-101 reduced haemorrhage volume and edema growth with no mortality in 23 ICH patients.
Bioxodes presented final BIRCH trial data at ESOC 2026, showing BIOX-101 reduced haemorrhage volume and edema growth with no mortality in 23 ICH patients.
Pharmaceuticals

BriaCell wins FDA clearance for Bria-BRES+ breast cancer IND

BriaCell Therapeutics can now initiate a Phase 1/2a study of its next-generation personalised cell immunotherapy in metastatic breast cancer.
BriaCell Therapeutics can now initiate a Phase 1/2a study of its next-generation personalised cell immunotherapy in metastatic breast cancer.
Regulatory Science

CDT Equity advances AZD5904 to PCT stage and seeks pharma partner

CDT Equity has filed for PCT patent protection on its myeloperoxidase inhibitor AZD5904 and is now actively seeking an out-licensing partner for late-stage
CDT Equity has filed for PCT patent protection on its myeloperoxidase inhibitor AZD5904 and is now actively seeking an out-licensing partner for late-stage
Diagnostics
Regulatory Science

Cellectar's iopofosine I 131 shows durable WM responses at 12 months

Phase 2b CLOVER WaM data show 83.6% ORR and 17.8-month median response duration, strengthening the case for accelerated FDA approval.
Phase 2b CLOVER WaM data show 83.6% ORR and 17.8-month median response duration, strengthening the case for accelerated FDA approval.
Regulatory Science

Cristcot names Rayna Herman to lead HCA commercial division

Austin-based Cristcot has hired a former Shorla Oncology CCO to head commercial preparations for its FDA-pending ngHCA suppository.
Austin-based Cristcot has hired a former Shorla Oncology CCO to head commercial preparations for its FDA-pending ngHCA suppository.
Regulatory Science

Cytokinetics' aficamten hits dual Phase 3 endpoints in nHCM

ACACIA-HCM met both primary endpoints — symptom burden and exercise capacity — marking the first positive Phase 3 trial in non-obstructive HCM.
ACACIA-HCM met both primary endpoints — symptom burden and exercise capacity — marking the first positive Phase 3 trial in non-obstructive HCM.
Regulatory Science

Dupixent shows esophageal function gains in Phase 4 EoE trial

Regeneron and Sanofi's REMODEL trial found dupilumab improved esophageal distensibility and reduced structural damage in adults with EoE at 24 weeks.
Regeneron and Sanofi's REMODEL trial found dupilumab improved esophageal distensibility and reduced structural damage in adults with EoE at 24 weeks.
Pharmaceuticals
Biotech

Electra Therapeutics doses first patient in ipsoprubart T cell trial

Electra's SIRP-targeting monoclonal antibody enters a dedicated Phase 1 study in T cell malignancies, supported by a 100% tumour response rate in a
Electra's SIRP-targeting monoclonal antibody enters a dedicated Phase 1 study in T cell malignancies, supported by a 100% tumour response rate in a
Cell & Gene Therapy

Ernexa's ERNA-101 clears tumours completely in ovarian cancer models

Ernexa Therapeutics reported 100% survival and complete tumour clearance for ERNA-101 combined with PD-1 blockade in preclinical ovarian cancer models.
Ernexa Therapeutics reported 100% survival and complete tumour clearance for ERNA-101 combined with PD-1 blockade in preclinical ovarian cancer models.
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