FDA

Ohtuvayre - an inhaled bronchodilator with non-steroidal anti-inflammatory effects - is the first new mechanism in COPD approved in more than 20 years.

Epkinly is a bispecific antibody now approved to treat both relapsed or refractory follicular lymphoma and relapsed or refractory diffuse large B-cell lymphoma.

The FDA cited issues related to a third-party manufacturer. The agency did not request any additional testing from AbbVie.

Krazati is already available to treat patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer.

Full approval was granted for the one-time gene therapy to ambulatory patients aged 4 years older. The FDA also granted accelerated approval to Elevidys for non-ambulatory patients.

Skyrizi is also available to treat patients with plaque psoriasis, psoriatic arthritis, and Crohn’s disease and has a list price of $21,017.36 for one dose.

Committee members, however, also said more data are needed on donanemab to treat patients in underrepresented patient groups, including Latin American and African American patients and special populations such as Down syndrome.

Tagrisso, which is already available to treat patients with non-small cell lung cancer and EGFR mutations, is being reviewed by the FDA for patients with this cancer and exon 19 deletions or exon 21 mutations.

The FDA is considering a monthly IV maintenance dose of Leqembi to treat people with Alzheimer’s disease. The action date is set for Jan. 25, 2025.

mRESVIA will be available for the 2024/2025 RSV season as a pre-filled, ready to use syringe.

Zolbetuximab is first-in-class monoclonal antibody. The FDA has assigned an action date of Nov. 9, 2024.

FDA officials have asked for additional analyses on the efficacy of Dupixent in the two pivotal trials. The revised target action date is Sept. 27, 2024.

Breyanzi is a CAR T-cell therapy now approved for four subtypes of non-Hodgkin lymphoma.

Onyda XR is a liquid form of clonidine that can be used as monotherapy or as adjunctive therapy for patients 6 years of age and older with ADHD.

Zanidatamab is bispecific antibody that targets HER2 in patients with metastatic biliary tract cancer. The FDA has set an action date of Nov. 29, 2024.

The FDA has set a Prescription Drug User Fee Act date of Nov. 27, 2024, to treat patients with PIK3CA-mutated HR-positive, HER2 negative metastatic breast cancer.

Bkemv is a monoclonal antibody that is approved to treat two rare conditions that break down red blood cells.