News

MedPage Today6h
Finerenone Gets Expanded FDA Approval in Heart Failure
The FDA expanded the indication for finerenone (Kerendia) in heart failure (HF), drug manufacturer Bayer announced.
MPR12h
FDA Drug Approval Decisions Expected in August 2025
The FDA is expected to decide on treatments for bronchiectasis, chronic immune thrombocytopenia, fibromyalgia, Friedreich ataxia, and recurrent respiratory papillomatosis.
Avidity Biosciences: Three Accelerated Approval Shots Feels Excessive
Del-zota is designed for patients with mutations amenable to exon 44 skipping, which is just 7% of the overall DMD patient ...
Clinical Advisor9h
FDA Fully Approves Moderna’s COVID Vaccine for Some Young Kids
The FDA action comes weeks after US Health Secretary Robert F. Kennedy Jr said the government would no longer recommend the COVID vaccine for healthy children or pregnant people.
FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says
It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...
The American Journal of Managed Care8h
Concerns Persist Over Reliance on Surrogate Endpoints in FDA Accelerated Approvals
Many FDA accelerated approvals continue to rely heavily on surrogate endpoints, raising ongoing uncertainty about the true clinical benefits of these therapies.
TCTMD6h
FDA Approves Finerenone for HF Patients With Mildly Reduced or Preserved EF
The US Food and Drug Administration has approved the use of finerenone (Kerendia) in heart failure (HF) patients with mildly ...
MPR12h
FDA Approves New Dosing Regimen for Kisunla in Alzheimer Disease
The Food and Drug Administration (FDA) has updated the labeling for Kisunla ™ (donanemab-azbt) to include a new recommended titration dosing schedule for adults with early symptomatic Alzheimer ...