FDA News

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.

The approval makes inebilizumab-cdon the first and only CD19-targeted B cell therapy indicated for anti-AChR and anti-MuSK Ab+ generalized myasthenia gravis.

Berotralstat (ORLADEYO) oral pellets become the first FDA-approved therapy specifically designed to prevent HAE attacks in children aged 2 – 11 years.

The approval of a dye- and preservative-free powder formulation of trofinetide offers a new option for adult and pediatric patients with Rett syndrome.

The FDA has announced a proposal to include bemitrizinol to its list of allowable active ingredients to include in sunscreens.

This approval of GSK plc’s gepotidacin as an oral option for patients with uncomplicated urogenital gonorrhea follows EAGLE-1 phase 3 trial findings.

The approval makes etuvetidigene autotemcel (Waskyra) the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome.

Teva submitted an NDA on olanzapine extended-release injectable suspension (TEV-‘749) for adult schizophrenia to the FDA.

The approval of Ayrmid’s omidubicel-onlv makes it the first hematopoietic stem cell transplant therapy to treat patients with severe aplastic anemia.

This FDA News Month in Review provides a round-up of regulatory decisions from November 2025.

The accelerated approval expands Avance use to motor, mixed, and long-gap sensory nerve injuries, with required confirmatory trials to verify clinical benefit.

Catch up with major FDA decisions, critical conference news, and more.