North America

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.

Kyntra Bio has amended its royalty financing deal to reduce maximum aggregate payments from $125m to $65m, extending its cash runway into Q4 2027.

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.

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

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

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

Alvotech's BLA for AVT80, a proposed interchangeable subcutaneous biosimilar to Entyvio, has been accepted for review by the FDA, completing its dual-presentation

The Canadian biotech cleared a central IRB review for its Phase II LSALT peptide study, bringing five U.S. institutions closer to activation.

Ascendis Pharma will pay BioMarin royalties of up to 20% on navepegritide net sales through May 2030 to resolve all litigation between the two companies.

Beyond Air's portable inhaled nitric oxide device gains FDA Breakthrough Device Designation for a rare, hard-to-treat chronic lung infection.

The FDA agreed on the primary endpoint and placebo-control design for Cadrenal's Phase 3 trial of its 12-LOX inhibitor in heparin-induced

Canada's Drug Agency has backed public reimbursement of lecanemab for early Alzheimer's disease, clearing the way for pCPA pricing negotiations.

Disc Medicine will share Phase 2 safety and efficacy data for two antibody candidates targeting myeloproliferative neoplasms at SOHO in Houston this September.

The French-American biotech has hired a 30-year industry veteran to lead operational and commercial readiness as its lanifibranor Phase 3 data approaches.

Twelve-month Phase 1/2a data showed 80% of patients normalised cardiac filling pressures after a single dose of the SERCA2a gene therapy.

Palvella Therapeutics has filed its full NDA with the FDA for QTORIN rapamycin gel, targeting a rare condition with no approved treatment options.

Updated interim PYNNACLE data show a 10-month median duration of response, as PMV plans an NDA submission for accelerated approval in Q1 2027.

BridgeBio's Attruby generated CMR evidence of cardiac structural reversal and 65 extra days alive out of hospital at three years in ATTR-CM patients.

The Nasdaq-listed biotech secured IP protection for its cannabinoid agonist's commercial formulation, extending coverage to 2041 across two active Phase 2 studies.

Autonomix Medical has been granted a US patent covering real-time feedback-guided precision neuromodulation systems, including neural ablation for cancer pain relief.