PT Staff

NVX-CoV2373, a protein-based COVID-19 vaccine, may increase the country's vaccination rate for those hesitant to receive other vaccines.

Hepatitis-associated emergency department visits and hospitalizations, liver transplantations, and adenovirus stool testing results in pediatric patients were not found to increase during the COVID-19 pandemic.

ProAir Digihaler Inhalation Powder is indicated for the treatment or prevention of bronchospasm in those with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Paxlovid treats COVID-19 in adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Clinical trial results show durable responses with mosunetuzumab in advanced follicular lymphoma.

Lisocabtagene maraleucel (liso-cel, Breyanzi; Bristol Myers Squibb) approved for the second-line treatment of patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, and follicular lymphoma grade 3B.

In clinical trials, dabrafenib and trametinib showed meaningful efficacy in multiple BRAF-positive tumor types, including in patients with rare cancers who have no other treatment options available.

Vaxneuvance is now indicated for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older.

The coexistence of hepatitis B virus (HBV) surface antigens and antibodies against are an atypical serological profile for patients with chronic HBV infections.

Risankizumab-rzaa (Skyrizi) is the first and only specific interleukin-23 inhibitor approved for the treatment of adults with moderately to severely active Crohn disease.

Since the COVID-19 pandemic began, more than 10.6 million children have tested positive for the virus in the United States.

Current development efforts in IVIG are focused on new routes of administration for immunoglobulin that can overcome the limitations of intramuscular administration.

Data from the phase 2/3 TeenCOVE trial in adolescents met the primary immunogenicity endpoint.

Baricitinib (Olumiant; Eli Lilly and Company) is the first systemic treatment to be approved by the FDA for severe alopecia areata, which affects an estimated 300,000 patients in the United States.

Real-world data show fremanezumab-vfrm (Ajovy) injection plus gepants combination effective in patients with difficult-to-treat migraine.

The FDA Vaccines and Related Biological Products Advisory Committee voted nearly unanimously for an emergency use authorization for the Novavax COVID-19 vaccine, NVX-CoV2373, for use in individuals 18 years of age and older.

Approval in this patient population makes dupilumab the first and only biologic medicine approved for the treatment of moderate-to-severe atopic dermatitis from infancy through adulthood.

In addition to the new approval for rheumatoid arthritis, Riabni has already been approved for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

Priorix can be administered as a first dose, followed by a second dose of Priorix, or as a second dose to those previously administered the first dose of another MMR-containing vaccine.

Trastuzumab deruxtecan shows superior and clinically meaningful progression-free survival and overall survival benefit in patients with HER2-low unresectable and/or metastatic breast cancer with hormone receptor-positive or negative disease.

Sacituzumab govitecan-hziy (Trodelvy) found to lower the risk of disease progression or death by 34% in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer.

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.