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FDA Approves Merck’s Welireg–Keytruda Combo as Adjuvant Treatment for Kidney Cancer

The FDA approved the combination of belzutifan (Welireg) and pembrolizumab (Keytruda)—or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)—for adjuvant treatment of adults with renal cell carcinoma with a clear cell component at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and metastatic lesion resection. Approval was based on results from the LITESPARK-022 trial, in which the combination reduced the risk of disease recurrence or death by 28% compared with pembrolizumab plus placebo as adjuvant therapy. The FDA granted this approval on June 12, 2026, giving patients at higher risk of kidney cancer recurrence an additional adjuvant treatment option after surgery. Sources: KEYTRUDA® (pembrolizumab) Plus WELIREG® (belzutifan) Given ... FDA approves belzutifan with pembrolizumab for adjuvant treatment ... FDA Approves Merck's KEYTRUDA® (pembrolizumab) as Adjuvant ... The FDA has approved Welireg + Keytruda for ad...

Enterome presents Phase 1/2 iNHL interim data at EHA demonstrating durable OncoMimics-induced CD8 T cell responses and clinical activity

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FDA hearing on Amgen's Tavneos will include findings from an independent review

Inside Astellas CEO's 5‑year plan to counter Xtandi's patent cliff

Genentech executes another round of layoffs, with 3 VPs axed

Enliven Therapeutics raises $400M in upsized offering

Novartis tightens bond with Orionis in up to $1.4B molecular glue deal - Biospace, European Biotechnology, LinkedIn, etc.

Takeda's AI‑designed psoriasis pill beats Bristol Myers Squibb's Sotyktu in Phase 3 head‑to‑head trial

Sensorion advances hearing loss gene therapy programs

Kardigan’s $320M IPO pitch: Three borrowed heart drugs, one proven cardio CEO

Kyntra Bio Presents New Roxadustat Data on Improvements in Transfusion Independence Regardless of Ring Sideroblast Status in Patients with Anemia due to Lower-Risk Myelodysplastic Syndromes

Explaining unapproved drugs to payors: FDA offers pharma new guidance to avoid pitfalls