November 26, 2025
Drug Approvals
Darzalex Faspro® (daratumumab/hyaluronidase-fihj) – Accelerated approval converted to traditional approval
November 19, 2025 - The FDA announced the traditional (full) approval of J&J’s Darzalex Faspro (daratumumab/hyaluronidase-fihj), in combination with bortezomib, cyclophosphamide and dexamethasone, for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.
Drug Approvals
Hyrnuo® (sevabertinib) – New orphan drug approval
November 19, 2025 - The FDA announced the approval of Bayer’s Hyrnuo (sevabertinib), for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
Drug Approvals
Imdelltra® (tarlatamab-dlle) – Accelerated approval converted to traditional approval
November 19, 2025 - The FDA announced the traditional (full) approval of Amgen’s Imdelltra (tarlatamab-dlle), for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
Drug Approvals
Jubereq® (denosumab-desu) – New biosimilar approval
November 20, 2025 - Accord announced the FDA approval of Jubereq (denosumab-desu), biosimilar to Amgen’s Xgeva® (denosumab).
Drug Approvals
Osvyrti™ (denosumab-desu) – New biosimilar approval
November 20, 2025 - Accord announced the FDA approval of Osvyrti (denosumab-desu), biosimilar to Amgen’s Prolia® (denosumab).
Drug Safety
Adzynma (ADAMTS13, recombinant-krhn) – FDA safety communication
November 21, 2025 - The FDA announced that they have received postmarketing reports of neutralizing antibodies to ADAMTS13, including one death, in patients treated with Adzynma (ADAMTS13, recombinant-krhn).
Clinical Updates
Eylea HD® (aflibercept) – New indication, updated dosing
November 19, 2025- Regeneron announced the FDA approval of Eylea HD (aflibercept), for the treatment of patients with macular edema following retinal vein occlusion (RVO).
Clinical Updates
Koselugo® (selumetinib) – Expanded indication
November 19, 2025 - The FDA announced the approval of AstraZeneca’s Koselugo (selumetinib), treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
Clinical Updates
Keytruda® (pembrolizumab)/Keytruda Qlex™ (pembrolizumab/berahyaluronidase alfa-pmph) plus Padcev® (enfortumab vedotin-ejfv) – New indication
November 21, 2025 - The FDA announced the approval of Merck’s Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab/berahyaluronidase alfa-pmph), in combination with Astellas’ Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.