PT Staff

Brentuximab vedotin (Adcetris) plus doxorubicin, vinblastine, and dacarbazine shows improved overall survival compared with standard chemotherapy in patients with previously untreated, advanced stage classical Hodgkin lymphoma.

An immune checkpoint inhibitor plus ramucirumab found to improve overall survival versus standard of care in patients with advanced non-small cell lung cancer.

Uliledlimab plus toripalimab (Tuoyi) shows significant response rates in patients with advanced non–small cell lung cancer previously ineligible to receive standard-of-care treatment.

Pegfilgrastim-pbbk is the third oncology biosimilar developed by Amneal to gain FDA approval this year.

Nivolumab (Opdivo) with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab (Yervoy) approved as first-line treatments for unresectable advanced or metastatic esophageal squamous cell carcinoma.

Intravenous immunoglobulin shows promise as a treatment option for pregnant patients with SARS-CoV-2, influenza, and other respiratory viruses.

The FDA previously placed a clinical hold on lenacapavir in borosilicate vials in all clinical studies because of emerging concerns about the compatibility of vials made of borosilicate glass.

The Labcorp Seasonal Respiratory Virus RT-PCR DTC Test is the first direct-to-consumer multi-analyte COVID-19 test to be authorized by FDA.

Tirzepatide is a once-weekly glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist indicated as an adjunct to diet and exercise in adults with type 2 diabetes.

Repotrectinib awarded breakthrough therapy designation for patients with ROS1-positive metastatic non–small cell lung cancer previously treated with a ROS1 tyrosine kinase inhibitor and who were not previously administered platinum-based chemotherapy.

Mesalamine is used to treat and prevent flare-ups of mild to moderately active ulcerative colitis.

After 14 months without ART, a patient with HIV only had transient detection of trace levels of HIV DNA in her blood cells after a stem cell transplant for acute myeloid leukemia.

Lifestyle-related factors, including food consumption, may significantly increase the chance of triggering a migraine headache.

Baricitinib (Olumiant) approved for the treatment of adult patients hospitalized with COVID-19 who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

Metronidazole is commonly used to treat Clostridium difficile infection, however, it has higher rates of therapy failure.

FDA action was based on an analysis for the risk of thrombosis with thrombocytopenia syndrome, a rare and potentially life-threatening condition that causes blood clots combined with low levels of blood platelets.

Trastuzumab deruxtecan (Enhertu) approved for adult patients with unresectable or metastatic HER2-positive breast cancer who were previously administered an anti–HER2-based regimen.

Trials results show darolutamide, docetaxel, and androgen deprivation therapy (ADT) reduced the risk of death by 32.5% versus docetaxel/ADT in patients with metastatic hormone-sensitive prostate cancer.

The Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) were previously granted priority review designation by the FDA for H. pylori infection.

FDA approves 15 mg upadacitinib (Rinvoq; AbbVie) for the treatment of adult patients with active ankylosing spondylitis who previously showed an inadequate response or intolerance to 1 or more tumor necrosis factor inhibitors.

Viloxazine extended-release capsules are indicated as a once-daily, flexible-dose nonstimulant drug for attention-deficit hyperactivity disorder.

Osteseconazole (Vivjoa) is the first FDA-approved treatment for recurrent vulvovaginal candidiasis, also known as chronic yeast infection, in women with a history of the condition who are not of reproductive potential.

Mavacamten is a first-in-class, oral, allosteric modulator of cardiac myosin designed to decrease contractile function and improve VO2 in patients with obstructive hypertrophic cardiomyopathy.

Ravulizumab-cwvz (Ultomiris) is the first and only long-acting C5 complement inhibitor for the treatment of generalized myasthenia gravis to gain FDA approval.

An engineered live biotherapeutic product may help limit antibiotic resistance versus pathogens such as Clostridioides difficile.

Fremanezumab is the second FDA-approved preventive migraine treatment that blocks the activity of calcitonin gene-related peptide.

Letermovir has been approved by the FDA to prevent severe CMV in patients who are asymptomatic and undergoing allogeneic hematopoietic stem cell transplants.

Investigational CAR T-cell therapy is currently being evaluated in an ongoing dose escalation phase 1 trial to analyze its safety and tolerability in treating non-Hodgkin lymphoma.

MIS-C is a rare complication of SARS-CoV-2 infection, which is characterized by symptoms such as fever, multiorgan involvement, and documented SARS-CoV-2 exposure.

Bevacizumab-maly (Almysys; mAbxience) is the third biosimilar of bevacizumab (Avastin) approved in the United States.