Pretzel Therapeutics receives UK trial authorisation for PX578 ahead of Phase 2 POLG disease study
Pretzel Therapeutics gains UK trial authorisation for PX578, paving the way for Phase 2 testing in POLG disease before year-end 2026.
Pharma & Biotech
Pharma & Biotech
Immunome’s varegacestat cut progression risk by 84%, but can it challenge an already approved European desmoid tumour treatment?
Immunome's varegacestat enters EMA review after strong RINGSIDE results, but safety, competition and approval remain key uncertainties.
Medical Devices & Diagnostics
SetPoint Medical completes first Boston implant of FDA-approved rheumatoid arthritis neurostimulation system
SetPoint Medical completes its first Boston RA implant, expanding access to FDA-approved vagus nerve therapy after positive RESET-RA results.
Pharma & Biotech
Can Ascletis ASC30 compete with established oral GLP-1 treatments?
Ascletis reports up to 1.7-point HbA1c reduction and 4.4% weight loss with oral ASC30, as larger trials must confirm safety and efficacy.
Medical Devices & Diagnostics
Glooko reports no severe hypoglycaemia in 267-patient EndoTool IV labour and delivery analysis
Glooko reports zero severe hypoglycaemia events in 267 patients using EndoTool IV during delivery, but neonatal outcomes remain unreported.
Pharma & Biotech
Neurogene reports rapid MECP2 expression and new gene regulation data for NGN-401 in Rett syndrome
Neurogene reports rapid MECP2 expression and new regulation data for NGN-401, strengthening its Rett syndrome research ahead of 2027 results.
Medical Devices & Diagnostics
Powerful Medical secures CPT code 1139T for Queen of Hearts AI ECG after FDA authorisation
Powerful Medical secures CPT code 1139T for Queen of Hearts AI ECG, opening a US billing pathway while reimbursement remains unresolved.
Pharma & Biotech
AbbVie submits FDA application for etentamig after Phase 3 CERVINO success in multiple myeloma
AbbVie seeks FDA approval for etentamig after Phase 3 myeloma results showed a 60% reduction in progression risk. Infection safety remains in focus.
Medical Devices & Diagnostics
Vincora secures FDA approval for NeXuS transcatheter chordal repair feasibility study in the US
Vincora gains FDA permission to study its NeXuS mitral repair system in the US, with procedural safety and lasting valve repair now in focus.
Pharma & Biotech
Pfizer’s TALZENNA and XTANDI cut prostate cancer progression risk by 52%, but who benefits most?
Pfizer wins FDA approval for TALZENNA plus XTANDI in earlier metastatic prostate cancer. See how a 52% progression-risk reduction changes treatment.