Pharmaceuticals
AstraZeneca's Baxfendy (baxdrostat) is the first aldosterone synthase inhibitor approved by the FDA, offering a fundamentally new approach to treating resistant hypertension in the 23 million Americans whose blood pressure remains uncontrolled despite multiple medications.
Biotechnology
Three competing technologies—from Sanofi, Wave Life Sciences, and Beam Therapeutics—are finally challenging Alpha-1 Antitrypsin Deficiency after four decades of limited treatment options.
Biotechnology
MediWound Ltd. (Nasdaq: MDWD) recently earned a spot in one of Europe's most exclusive health security forums, and the timing could not be more relevant.
Biotechnology
Regeneron's Phase 3 HARMONY trial of fianlimab plus cemiplimab missed statistical significance in melanoma despite a 5.1-month PFS improvement. What the p-value of 0.0627 reveals about dual checkpoint blockade.
Biotechnology
AstraZeneca's VOLGA Phase 3 trial delivers a statistically significant overall survival benefit for cisplatin-ineligible muscle-invasive bladder cancer patients, marking a turning point for a population that has long been underserved by perioperative treatment options.
Policy
Marty Makary's sudden resignation as FDA commissioner leaves the pharmaceutical industry facing regulatory uncertainty at a critical moment for biotech recovery.
Pharmaceuticals
The FDA approves Inqovi in combination with venetoclax as the first all-oral treatment for elderly patients with newly diagnosed AML, eliminating the need for frequent infusion center visits.
Biotechnology
Sarepta's Elevidys gene therapy beats revenue estimates but faces declining sales, revealing the gap between clinical promise and commercial durability in the gene therapy sector.
Biotechnology
argenx's VYVGART receives FDA approval for all generalized myasthenia gravis patients regardless of serotype, including the triple seronegative population previously excluded from treatment options.
Biotechnology
Roche's $1.05 billion acquisition of PathAI signals that AI-powered digital pathology is becoming as strategically important as drug development itself in precision oncology.
Biotechnology
Bayer's $2.45 billion acquisition of Perfuse Therapeutics signals a strategic shift in ophthalmology toward disease-modifying treatments that could reverse vision loss in glaucoma and diabetic retinopathy—conditions affecting over 200 million people worldwide.
Biotechnology
Cytokinetics' ACACIA-HCM Phase 3 trial just delivered the first statistically significant win in non-obstructive HCM. Here is what the data mean, why the disease has been so hard to treat, and what comes next for aficamten and the field.