Regulation

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.

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

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.

XYRA LLC has dosed the first patient in Poland in HARBOR-AF, a Phase 2/3 study using wearable and implanted monitors to guide antiarrhythmic

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.

The Danish medtech reported solid third-quarter trading across Chronic Care but flagged a 6% sales decline in Biologics due to reimbursement changes.

HUTCHMED's Phase III SANOVO trial met its primary endpoint in treatment-naïve MET-overexpressing EGFR-mutated NSCLC, with an encouraging early overall survival signal.

Leios Therapeutics has signed an exclusive licensing deal with CMS subsidiaries covering mainland China, its second major regional deal this year.

Dublin-based Trinity Biotech has requested a Nasdaq hearing after failing to meet the exchange's minimum market value threshold by its August deadline.

The Melbourne biopharmaceutical company reported FY2026 net profit of A$33.9m and plans to use its balance sheet strength to accelerate US expansion.

The capsule endoscopy company reported Q2 2026 revenue of $3.6m and expects US clearance of its AI-assisted reading tool by end of Q3.

New analyses from ACACIA-HCM and MAPLE-HCM presented at ESC 2026 strengthen aficamten's case across both obstructive and non-obstructive HCM subtypes.