FDA News

Catch up on the most impactful headlines in hormonal disorders from all of 2025 with our Year in Review.

FDA clears first human umbilical cord–derived sheet device, Theracor, for wound Care

The FDA grants breakthrough therapy designation for ulizacaltamine for the treatment of essential tremor.

Catch up on the most impactful headlines in HF from all of 2025 with our Year in Review.

Catch up on the most impactful headlines in cardiology from all of 2025 with our Year in Review.

The FDA has approved small-molecule pyruvate kinase R activator mitapivat for the treatment of anemia in adults with alpha- or beta-thalassemia.

The approval indicates narsoplimab as the first and only treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy.

Catch up on the most impactful headlines in dyslipidemia from all of 2025 with our Year in Review.

The FDA has approved an sNDA for the FUROSCIX On-body Infusor in pediatric patients and accepted another for the FUROSCIX ReadyFlow Autoinjector.

The approval is based on the 64-week phase 3 OASIS 4 trial showing an average weight loss of ~17% if all patients stayed on treatment with semaglutide and ~14% regardless of if patients stayed on treatment.

Catch up on the most impactful headlines in ophthalmology from all of 2025 with our Year in Review.

The FDA’s decision is based on positive results from the phase 3 THRIVE and THRIVE-2 clinical trials, which showed veligrotug’s efficacy and rapid onset of benefits.

Catch up on the most impactful headlines in T2D from all of 2025 with our Year in Review.

The approval is based on phase 3 SEQUOIA-HCM clinical trial. The full US Prescribing Information includes a Boxed Warning for the risk of heart failure.

The decision makes nerandomilast the first and only PDE4B inhibitor with immunomodulatory and antifibrotic effects approved in this indication.

Grifols’ fibrinogen concentrate is now approved for acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency.

Depemokimab-ulaa is the first and only ultra-long-acting biologic with twice-yearly dosing for patients with severe asthma with an eosinophilic phenotype.

Kereiakes discusses the potential of lerodalcibep for adults with hypercholesterolemia and high LDL-C, highlighting recent FDA approval.

Following the addition of a clinical study report to the NDA on December 12, the regulatory agency has extended the review period for the RASP inhibitor.

FibroGen’s oral HIF-PH inhibitor showed improved transfusion independence in high–high-transfusion-burden MDS patients in a post hoc phase 3 MATTERHORN analysis.

The Holly system is a first-of-its-kind implantable, continuous dialysis system designed to give patients freedom from the cycle of center-based dialysis.

FDA approves lerodalcibep, a groundbreaking PCSK9 inhibitor, offering a monthly injection for LDL cholesterol reduction in patients with HoFH.

The FDA has approved etripamil nasal spray for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia to sinus rhythm.

FDA approves zoliflodacin (Nuzolvence) for uncomplicated gonorrhea, offering a new oral treatment amid rising antibiotic resistance.