US 6421455

Medicare price rule could hit Keytruda and Opdivo subcutaneous launches

Medicare · cancer · 5 min

CMS is proposing a Medicare drug price rule that could shape the outlook for subcutaneous Keytruda and Opdivo. The products are expected to be eligible for selection in the 2027 negotiation round for IPAY 2029.

FDA approves belzutifan plus pembrolizumab for adjuvant RCC

FDA · renal cell carcinoma · 6 min

The FDA approved belzutifan plus pembrolizumab as adjuvant therapy for clear cell renal cell carcinoma at high risk of recurrence after nephrectomy. The catalyst is based on phase 3 LITESPARK-022 data and adds another regulatory milestone for belzutifan.

FDA priority review advances belzutifan plus pembrolizumab in adjuvant RCC

FDA · adjuvant renal cell carcinoma · 6 min

The FDA granted priority review to supplemental applications for belzutifan plus pembrolizumab in adjuvant renal cell carcinoma. The move extends Merck’s renal cancer catalyst path after evidence showed improved disease-free survival versus pembrolizumab alone.

FDA Approves Lumasiran for PH1: What BD and Investors Should Know

FDA · Acute Hepatic Porphyria · 8 min

This rewrite clarifies that FDA-approved Givlaari (givosiran) is indicated for adults with acute hepatic porphyria, while OXLUMO (lumasiran) is approved for PH1. The article should frame the catalyst as a regulatory and portfolio update, not a new AHP label for lumasiran.