Kerendia™ (finerenone) – New drug approval

The FDA announced the approval of Bayer’s Kerendia (finerenone), to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). July 9, 2021

Aduhelm™ (aducanumab-avwa) – Updated labeling

Biogen announced the FDA approval of updated labeling for Aduhelm (aducanumab-avwa), emphasizing that Aduhelm should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. July 8, 2021

Darzalex Faspro® (daratumumab and hyaluronidase-fihj) – Expanded indication

Janssen announced the FDA approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj), in combination with Pomalyst® (pomalidomide) and dexamethasone, for the treatment of adult patients with multiple myeloma in patients who have received at least one prior line of therapy including Revlimid® (lenalidomide) and a proteasome inhibitor. July 12, 2021

Keytruda® (pembrolizumab) – Expanded indication

Merck announced the FDA approval of Keytruda (pembrolizumab), for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. July 6, 2021

Padcev® (enfortumab vedotin-ejfv) – Expanded indication

Seagen and Astellas Pharma announced the regular FDA approval and expanded indication for Padcev (enfortumab vedotin-ejfv). July 9, 2021