Davy James

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.

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.

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.

Besponsa (inotuzumab ozogamicin) was initially approved in August 2017 for adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

The biosimilars Wyost and Jubbonti (denosumab-bddz) were approved as interchangeable products for Prolia and Xgeva for the treatment of osteoporosis, hypercalcemia, and to prevent skeletal-related events associated with bone metastases from solid tumors.

Regulatory action makes Rybrevant plus chemotherapy the first FDA-approved therapy for the first-line treatment of non-small cell lung cancer with EGFR exon 20 insertion mutations.

IDP-023 is a highly potent natural killer cell platform under evaluation for patients with multiple myeloma and non-Hodgkin lymphoma.

Abrysvo was found to produce durable efficacy against respiratory syncytial virus across two seasons in adults 60 years of age and older.

Trogarzo (ibalizumab-uiyk) is currently approved in combination with other antiretroviral therapy for heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen.

NVL-520 is a novel, brain-penetrant, ROS1-selective tyrosine kinase inhibitor under evaluation for patients with metastatic ROS1-positive non–small cell lung cancer.

The FDA granted Allecra with a five-year marketing exclusivity extension for Exblifep (cefepime/enmetazobactam) through the Generating Antibiotic Incentives Now Act.

Trial data support Tevimbra combined with chemotherapy as a potential first-line treatment option for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction cancer.

Epkinly (epcoritamab-bysp) is a subcutaneously administered, T-cell engaging, immunoglobulin G1-bispecific antibody under evaluation for aggressive B-cell lymphomas.

BAY 2927088 is an oral, reversible small molecule tyrosine kinase inhibitor being analyzed for the treatment of unresectable or metastatic non-small cell lung cancer with tumors that have activating HER2 mutations.

Survodutide, a GLP-1 receptor dual agonist with a novel mechanism of action, was the first treatment to produce findings this significant in a Phase II trial of metabolic dysfunction-associated steatohepatitis.

The FDA has assigned a supplemental Biologics License Application submitted by Regeneron and Sanofi for Dupixent in the treatment of COPD with type 2 inflammation with a PDUFA date of June 27, 2024.

SKYTyphoid showed a positive immunogenicity and safety profile compared to other polysaccharide-protein conjugate typhoid vaccines that obtained prequalification certification by the World Health Organization.

Ocifisertib is a first-in-class, novel PLK4 inhibitor that has demonstrated significant activity as a monotherapy in both solid and liquid tumors.

The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024.

Injectable long-acting Cabenuva (cabotegravir + rilpivirine) produced superior efficacy in viral load suppression compared with daily oral antiretroviral therapy in patients with HIV who have adherence challenges.