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Apr 20, 2026
Bayer’s sevabertinib has obtained domestic approval as an imported rare drug for HER2-mutant non-small cell lung cancer. The oral reversible HER2-targeted TKI was previously approved by the FDA for previously treated patients.
Mar 31, 2026
Pharmaceutical companies are delaying European drug launches due to uncertainty over U.S. pricing policies under President Trump. New drug launches in EU markets fell 35% following Trump's executive order on international reference pricing. Companies fear lower European prices could undermine their ability to maintain higher prices in the $700 billion U.S. market.
Mar 29, 2026
Bayer achieved its upgraded 2025 financial targets with group sales reaching 45.6 billion euros and projects solid 2026 performance. The company's pharmaceutical business shows rejuvenation with launch medicines becoming growth drivers, while Crop Science progresses in profitability improvement. Bayer continues strategic diversification in oncology and addresses litigation challenges while implementing cost-saving measures.
Mar 19, 2026
Bayer's Phase III FIND-CKD trial shows finerenone significantly slows kidney function decline in non-diabetic chronic kidney disease patients. The drug met its primary endpoint with improved eGFR slope over 32 months, marking its fifth consecutive positive Phase III trial. Bayer plans to submit the data to the FDA for label expansion into non-diabetic CKD.
Mar 13, 2026
Zydus Lifesciences launched ANYRA, India's first indigenously developed aflibercept biosimilar, on February 19, 2026, following an agreement with Regeneron Pharmaceuticals and Bayer for multiple ophthalmic indications.
Mar 12, 2026
The global radioligand therapy market is projected to grow from $2.6 billion in 2025 to $4.8 billion by 2030 at 13.1% CAGR, driven by FDA label expansions, earlier-line treatment positioning, and substantial private investment in isotope production infrastructure.
Mar 09, 2026
The FDA approved Bracco's Vueway for neonates and infants at half the standard gadolinium dose, accepted Bayer's gadoquatrane application for a 60% dose reduction, and granted Breakthrough Device designation to Radiology Partners' AI chest X-ray tool.
Mar 08, 2026
Maryland-based CDMO Xcellon Biologics introduces the Xcellerate Program to provide early-stage biotech companies with reduced-cost development support for complex biologics and antibody-drug conjugates, addressing the funding gap between seed stage and institutional investment.
Mar 05, 2026
Finerenone met its primary endpoint in reducing albuminuria in type 1 diabetic kidney disease, marking the first successful drug trial in 30 years for this population. Separately, SGLT2 inhibitors showed superior kidney protection compared to GLP-1 medications in type 2 diabetes patients.
Mar 02, 2026
Samsung Bioepis reached settlement agreements with Regeneron and Bayer for its aflibercept biosimilar OPUVIZ, enabling U.S. launch in January 2027 and staged international rollout beginning early 2026.
Feb 27, 2026
Zydus Lifesciences launched ANYRA, India's first indigenous Aflibercept biosimilar for retinal conditions, and secured approval for a March 2026 day-one launch of generic semaglutide for diabetes and obesity treatment.
Feb 25, 2026
Cytokinetics launches MYQORZO for obstructive hypertrophic cardiomyopathy following FDA approval, while C4 Therapeutics doses first patient in Phase 2 trial of cemsidomide for relapsed/refractory multiple myeloma.
Feb 15, 2026
DelveInsight releases three separate pipeline reports covering metastatic prostate cancer (80+ companies, 85+ drugs), iPSC-derived NK cells (12+ companies, 15+ drugs), and interstitial lung diseases (120+ companies, 120+ drugs), highlighting recent regulatory approvals, trial launches, and emerging therapies.
