The United States Food and Drug Administration approved Bayer’s Kerendia (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist indicated to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes.
The U.S. Food and Drug Administration granted Seagen Inc. and Astellas Pharma Inc.’s Padcev (enfortumab vedotin-ejfv) regular approval in the United States, in addition to approving a new indication for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
Drugmakers AstraZeneca and Amgen said on July 8 their experimental drug tezepelumab was granted a speedy review by the U.S. Food and Drug Administration for potential approval as a treatment for asthma.
Valneva SE was awarded Breakthrough Therapy Designation for the company’s single-shot chikungunya vaccine candidate, VLA1553, by the U.S. Food and Drug Administration.
After the July 4 holiday, the U.S. Food and Drug Administration has several items on the regulatory agency’s immediate calendar, including a couple target action dates and an advisory committee hearing.
Novartis will manufacture the anti-cholesterol medicine Leqvio at the company’s own plant in Austria to supply the United States as the Swiss drugmaker seeks U.S. approval that has been delayed by regulatory concerns over a contractor’s Italian facility.
The U.S. Food and Drug Administration on July 6 declined to approve Provention Bio Inc.’s experimental diabetes drug, citing insufficient data, sending the company’s shares down about 28 percent
The U.S. Food and Drug Administration approved an expanded label for Merck’s anti-PD-1 therapy Keytruda as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
The U.S. Food and Drug Administration authorized the use of an additional batch of Johnson & Johnson’s one-dose Covid-19 vaccine manufactured at the problem-plagued Baltimore factory of Emergent BioSolutions Inc.
Jazz Pharmaceuticals won U.S. regulatory approval for a new leukemia drug aimed at patients who have developed hypersensitivity to E. coli-derived asparaginase, an enzyme that is a component of the chemotherapy regimen used to treat acute lymphoblastic leukemia (ALL).
