Regulatory

Evolut FX+ transcatheter aortic valve replacement system design includes a larger coronary access window through a modified frame.

Action marks the first FDA-approved blood screening test for malaria.

Winrevair is the first FDA-approved activin signaling inhibitor therapy for pulmonary arterial hypertension.

Alexander continues her conversation, touching on topics like disinformation and diversity in clinical trials.

Alexander discusses the broader implications the case could have on FDA's ability to regulate the industry.

Action marks the first FDA approval of a long-acting treatment for adult patients with neuromyelitis optica spectrum disorder who are positive for the anti-aquaporin-4 antibody.

The FDA granted accelerated approval to Elahere in November 2022 for patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who were previously administered one to three systemic treatment regimens.

In clinical trials, the newly approved Opsynvi led to a greater drop in pulmonary vascular resistance after 16 weeks compared with both tadalafil and macitentan monotherapy.

Duvyzat (givinostat) is histone deacetylase inhibitor that was previously granted priority review, orphan drug designation, and rare pediatric disease designation by the FDA for patients 6 years of age and older with Duchenne muscular dystrophy.

Valder Curran discusses recent developments with the IRA.

MVR-T3011 IT is in development to treat patients with recurrent or metastatic head and neck squamous cell cancer whose disease progressed following platinum-based chemotherapy and at least one prior line of a PD-1/PD-L1 therapy.

Tryvio (aprocitentan) approved in combination with other antihypertensive drugs to lower hypertension in adults whose blood pressure is not adequately controlled by other therapies.

Expanded indication for Edurant in combination with other antiretroviral therapies includes treatment-naïve children with HIV-1 RNA <100,000 copies/mL aged at least 2 years and weighing between 14 kg and 25 kg.

Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.

Indication of Spevigo (spesolimab-sbzo) expanded for the treatment of generalized pustular psoriasis in patients 12 years of age and older weighing ≥40 kg.

In a unanimous decision, the committee recommended Carvykti based on promising data from the Phase III CARTITUDE-4 study, which showed a positive risk-benefit assessment.

Tevimbra (tislelizumab-jsgr) has been approved as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors.

CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) approved for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously administered at least two lines of therapy.

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) was granted accelerated approval for the treatment of adult patients with noncirrhotic nonalcoholic steatohepatitis (NASH).

Regeneron’s PCSK9 inhibitor approved to reduce low-density lipoprotein cholesterol in patients 8 years of age and older with heterozygous familial hypercholesterolemia.

FDA approves Wegovy (semaglutide) to lower the risk of major adverse cardiovascular events in adults with known heart disease and with either obesity or overweight, in addition to a reduced calorie diet and increased physical activity.

Because of the unique trial design of the Phase III TRAILBLAZER-ALZ 2 study, the FDA is seeking additional input regarding the safety and efficacy of donanemab for the treatment of early symptomatic Alzheimer disease.

BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies.

Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in patients with unresectable or metastatic urothelial carcinoma.

Medication is the first tocilizumab biosimilar approved in the US for both IV and subcutaneous use for autoimmune diseases, such as rheumatoid arthritis and juvenile idiopathic arthritis.