The FDA has approved Merck KGaA’s Pimjetmi for the treatment of tenosynovial giant cell tumor, marking another step for the Germany-based company’s rare-tumor strategy. The approval adds to Merck KGaA’s growing portfolio of assets acquired through prior business deals aimed at niche oncology indications. For biotech stakeholders, the decision highlights continued regulatory openness to rare-disease oncology programs and reinforces how label expansion can drive commercial momentum when clinical development is tightly focused on uncommon tumor types.