PT Staff

Faricimab is the first and only bispecific antibody granted FDA approval for treatment of the eye.

Mirikizumab-mrkz (Omvoh; Eli Lilly and Company) is the first IL-23p19 antagonist approved for adult patients with moderately to severely active ulcerative colitis.

A weekly dose of injectable lecanemab-irmb (Leqembi) could allow patients with Alzheimer disease to receive the drug at home instead of visiting an infusion center twice per month.

Nirsevimab-alip (Beyfortus; Sanofi and AstraZeneca) is a monoclonal antibody approved to prevent against respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants under 8 months of age born during or entering their first RSV season.

mRNA-1083 is an investigational combination vaccine designed to prevent influenza and COVID-19.

Infliximab-dyyb (Zymfentra; Celltrion USA) is a subcutaneous treatment for the maintenance treatment of adults with moderately to severely active ulcerative colitis and Crohn disease.

Penbraya (Pfizer Inc) is the first and only approved pentavalent vaccine that confers protection against the most common meningococcal serogroups—A, B, C, W-135, and Y, in individuals 10 through 25 years of age.

Bimekizumab is a novel, humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-7A and IL-17F, which are key cytokines driving inflammatory processes in plaque psoriasis.

Pembrolizumab (Keytruda) gains its sixth approval in non–small cell lung cancer (NSCLC), with the latest indication in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a monotherapy for the post-surgical adjuvant treatment of patients with resectable NSCLC.

In clinical trials, nivolumab (Opdivo) demonstrated a statistically significant improvement in recurrence-free survival compared to placebo in eligible patients with stages IIB, IIC, III, and stage IV completely resected melanoma.

Encorafenib (Braftovi; Pfizer Inc) and binimetinib (Mektovi; Pfizer Inc) approved for the treatment of patients with metastatic non-small cell lung cancer who harbor a BRAF V600E mutation.

Study shows a a significant burden of hospitalizations associated with respiratory syncytial virus during the 2021-2022 season compared with the prepandemic period.

NVX-CoV2601 vaccine adjuvanted 2023-2024 formula granted EUA for the prevention of COVID-19 in those 12 years of age and older.

Bosutinib (Bosulif) is indicated to treat pediatric patients with Philadelphia chromosome–positive chronic-phase chronic myelogenous leukemia that is newly diagnosed, resistant, or intolerant to previous therapy.

Most patients with myelofibrosis will develop anemia over the course of the disease, with more than 30% discontinuing treatment as a result.

Products include Cyanocobalamin Nasal Spray, Chlorpromazine Hydrochloride Tablets USP, Tiotropium Bromide Inhalation Powder, 18 mcg/ capsule, and Sevelamer Hydrochloride Tablets USP.

Products include Nirsevimab-alip, Remdesivir, Inclisiran, and Lecanemab-irmb.

Products include prose skin care, ESPADA 2 plus, hair blend line, and a warm eye mask.

The fixed-dose abacavir/dolutegravir/lamivudine combination is indicated for the once-daily treatment of children weighing at least 6 kg to <25 kg with HIV-1 infection.

Luspatercept-aamt (Reblozyl) approved to treat adults with very low- to intermediate-risk myelodysplastic syndrome who may require regular red blood cell transfusions.

This months generic product news includes azithromycin tablets, minocycline hydrochloride tablets, carboprost tromethanmine injection, and tadalafil tablets.

Elranatamab-bcmm (Elrexfio; Pfizer) is a BCMA-CD3-targeted bispecific antibody approved for adults with relapsed or refractory multiple myeloma who were previously administered at least 4 lines of therapy that included a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Niraparib and abiraterone acetate (Akeega; Janssen Pharmaceutical Companies of Johnson & Johnson) is the first-and-only dual action tablet that combines a PARP inhibitor with abiraterone acetate administered with prednisone.

Talquetamab-tgvs (Talvey) is a first-in-class bispecific antibody that binds to GPRC5D and CD3 to induce T cell-mediated killing of GPRC5D-expressing multiple myeloma cells.

Lisaftoclax is a novel, oral, small-molecule, BCL-2 selective inhibitor being evaluated for treatment of relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.