Regulation

All five Cohort 1 participants showed clinically meaningful visual improvement, and the FDA has aligned on a potential pivotal endpoint for the rare retinal disease

Exploratory analyses from the Phase 3 PROPEL 3 trial show oral infigratinib reduced otitis media rates by 38% and stabilised sleep apnea measures versus placebo.

The designation accelerates review of the dual IRAK1/JAK2 inhibitor in a rare autoinflammatory disease with no approved treatments; topline Phase 2 data expected in

SOTIO Biotech has initiated its CADENCIA-01 Phase 1/2 trial of SOT109, the only CDH17-targeting ADC with FDA Fast Track Designation, in advanced

The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.

St. George's University and UAE school group Taaleem have signed an MoU giving eligible students access to MD admissions pathways and up to USD

The Cambridge, Massachusetts biotech secured FDA acceptance of its Oxnimbi NDA with a PDUFA date of 28 February 2027, as it raised $221m in a

Dyne will present pooled Phase 1/2 data for z-basivarsen against a matched natural history cohort, with registrational topline results due Q1 2027.

Pharvaris's CHAPTER-3 Phase 3 study of once-daily deucrictibant XR met all endpoints, with NDA submissions planned for the first half of 2027.

Phase 2 PHocus trial showed a 56.3% placebo-adjusted PVR reduction; Roivant has now initiated the Phase 3 PHrontier study in the same indication.

Vor Bio has fully enrolled its global Phase 3 gMG study and will initiate a sister trial in ocular myasthenia gravis, with topline data expected

The Nasdaq-listed oncology company has detailed patents covering APR-1051 and ATRN-119, with WEE1 protection potentially running to 2047.

Lakeland's Hong Kong subsidiary has secured a follow-on contract to supply flame-resistant foul weather suits to Hong Kong Government Flying Service pilots

NorthStrive Biosciences has filed two US patent applications extending its myostatin-targeting probiotic candidates into microgravity-induced muscle atrophy.

Del-desiran failed to improve hand myotonia in a 150-patient Phase III study, though secondary endpoints showed signs of clinical activity.

Phase 3 STEP Young data show 40.4% of children aged 6 to 11 treated with semaglutide dropped below the obesity BMI threshold after 68

The Belgian medtech has begun a 229-patient, five-year US real-world study of its Genio bilateral hypoglossal nerve stimulator, approved by the FDA

The EPO has granted Vaxart protection for its room-temperature, needle-free norovirus pill vaccine across 13 European markets until at least 2036.

Zentalis is raising fresh capital via an underwritten public offering to fund trials and pre-commercial activities for its WEE1 inhibitor azenosertib in ovarian cancer.

AMS posted 19% year-on-year Q2 revenue growth to $8.4m, led by a 40% surge in direct patient services across its US and