Edison Scientific signs Pfizer agreement to deploy Kosmos AI scientist across pharmaceutical R&D
Edison Scientific partners with Pfizer to deploy Kosmos across drug R&D, testing whether AI can turn decades of research data into better decisions.
Medical Devices & Diagnostics
Features & Analysis
Pfizer TUKYSA gains FDA approval for first-line HER2-positive metastatic breast cancer maintenance
Pfizer’s TUKYSA gained first-line HER2-positive breast cancer maintenance approval after extending median PFS by 8.6 months.
Pharma & Biotech
Pfizer takes Tukysa into first-line HER2+ breast cancer maintenance after 8.6-month PFS gain
FDA approval moves Pfizer’s Tukysa into first-line maintenance for HER2-positive metastatic breast cancer after the regimen extended median progression-free survival from 16.3 to 24.9 months, although severe hepatotoxicity has emerged as an important treatment consideration.
Pharma & Biotech
Pfizer’s LITFULO cleared a major Phase 3 hurdle in vitiligo, but the missing numbers could decide its future
Pfizer’s Phase 3 LITFULO vitiligo results strengthen its filing case, but dose, safety and durability details remain decisive.
Pharma & Biotech
Scancell secures path to $89m financing through Neuphoria Therapeutics merger
Scancell will acquire Neuphoria Therapeutics and pursue up to $89 million to fund the Phase 3 iSCIB1+ melanoma trial through 2028.
Pharma & Biotech
Can Keytruda plus Padcev replace cisplatin chemotherapy before bladder cancer surgery?
FDA approval moves Keytruda and Padcev into perioperative MIBC regardless of cisplatin eligibility, intensifying the contest for standard care.
Pharma & Biotech
Pfizer and Astellas secure wider FDA label for Padcev plus Keytruda in muscle-invasive bladder cancer
FDA expands Padcev plus Keytruda to adults with muscle-invasive bladder cancer regardless of cisplatin eligibility, reshaping perioperative care.
Pharma & Biotech
Lupin’s tentative FDA approval for enzalutamide sets up a high-value generic challenge to Xtandi
Lupin Limited has moved closer to the United States enzalutamide market with proposed 120 mg and 160 mg tablets that could reduce pill burden. Patent timing, final approval, market access and competition will determine whether that formulation advantage becomes commercially meaningful.
Pharma & Biotech
Pfizer’s Ibrance wins broader FDA role as metastatic breast cancer treatment becomes more complex
The FDA approval brings CDK4/6 inhibition into HR-positive, HER2-positive metastatic breast cancer maintenance, although toxicity, immature survival data and a rapidly changing first-line market could shape adoption.
Pharma & Biotech
Sigvotatug vedotin Phase 3 miss tests Pfizer’s case for integrin beta-6 targeted ADCs
Discover why Pfizer’s sigvotatug vedotin Phase 3 miss shifts attention to second-line patients, biomarkers and first-line combinations.