Azelastine hydrochloride, a histamine-H1 receptor antagonist, has been marketed as a 0.1% nasal spray (Astelin - Wallace) for treatment of seasonal allergic rhinitis. Corticosteroid and cromolyn sodium nasal sprays are also available for this indication (Medical Letter, 37:5, 1995). Cromolyn sodium (Nasalcrom) has now been approved for over-the-counter use.

Temsirolimus (Torisel - Wyeth), an mTOR (mammalian target of rapamycin) kinase inhibitor that is metabolized to sirolimus (rapamycin), has been approved by the FDA for intravenous treatment of advanced renal cell carcinoma.

Obeticholic acid (Ocaliva – Intercept), a farnesoid X receptor agonist, has been approved by the FDA for treatment of primary biliary cholangitis; it is indicated for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso, and others) in adults with an inadequate response to UDCA and as monotherapy in adults unable to tolerate UDCA. Obeticholic acid is the second drug to be approved for this indication; UDCA was the first.

Teplizumab-mzwv (Tzield – Provention Bio), an anti-CD3 monoclonal antibody, has been approved by the FDA to delay the onset of stage 3 type 1 diabetes in patients ≥8 years old who have stage 2 type 1 diabetes. It is the first drug to become available in the US that delays the onset of type 1 diabetes.

Ixabepilone (ix ab ep' i lone; Ixempra - Bristol-Myers Squibb), a semisynthetic epothilone analog, has been approved by the FDA for treatment of advanced breast cancer. It is indicated for use in combination with capecitabine (Xeloda - Roche) for treatment of locally advanced or metastatic breast cancer after failure of an anthracycline such as doxorubicin (Adriamycin) and a taxane such as paclitaxel (Taxol, and others). It is also approved as monotherapy for treatment of metastatic or locally advanced breast cancer after an anthracycline, a taxane and capecitabine have...

The FDA has approved inotuzumab ozogamicin (Besponsa – Pfizer), a humanized anti-CD22 monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin, for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. It is the first CD22-directed antibody-drug conjugate to be approved in the US.

The FDA has approved loteprednol etabonate ophthalmic suspension 0.25% (Eysuvis – Kala) for short-term treatment (≤2 weeks) of dry eye disease. It is the first ocular corticosteroid to be approved for this indication. Other formulations of loteprednol are approved for treatment of steroid-responsive ocular inflammatory conditions, inflammation after ocular surgery, and seasonal allergic conjunctivitis.

The FDA has approved Apretude (ViiV Healthcare), an IM extended-release (ER) formulation of the integrase strand transfer inhibitor (INSTI) cabotegravir, for use every 2 months to prevent sexually acquired HIV-1 infection in at-risk adolescents and adults. Apretude is the first ER formulation to be FDA-approved for pre-exposure prophylaxis (PrEP) of HIV-1 infection.

Disruption of tear-film homeostasis (altered composition, reduced production, rapid evaporation) and resulting ocular surface inflammation cause the discomfort and blurred vision of dry eye disease. Many cases are caused by tear evaporation due to meibomian gland dysfunction. Other precipitating factors can include lacrimal gland dysfunction, poor eyelid function, environmental factors, extended screen time, inflammatory conditions such as Sjögren's syndrome, and use of some ocular or systemic drugs such as antihistamines, retinoids, or selective serotonin reuptake inhibitors...

Panitumumab (Vectibix - Amgen), a fully human IgG₂ monoclonal antibody that inhibits the epidermal growth factor receptor (EGFR), has been approved by the FDA for treatment of patients with EGFR-expressing metastatic colorectal cancer that has progressed despite standard chemotherapy. It is the second monoclonal antibody EGFR inhibitor to be approved for metastatic colorectal cancer; cetuximab (Erbitux), a human-murine chimeric IgG₁ monoclonal antibody, was approved in 2004.