FDA

Ocrevus Zunovo can be administrated by providers twice a year with a 10-minute subcutaneous injection. Ocrevus Zunovo will be available in a few weeks and be priced at parity with Ocrevus IV.

Tecentriq Hybreza will be available in a few weeks and be priced at parity with the IV Tecentriq 1200 mg vial.

Tremfya, a monoclonal antibody that blocks IL-23, is also approved to treat patients with plaque psoriasis and active psoriatic arthritis.

If approved, neffy would be the first new delivery method in more than 35 years for small children.

The FDA has given mirdametinib a Prescription Drug User Fee Act (PDUFA) action date of Feb. 28, 2025, to treat patients with neurofibromatosis type 1 with tumors that grow along the peripheral nerve.

The updated vaccines include the KP.2 strain of the Omicron variant, which is believed to be contributing to the increases in COVID-19 infections this summer.

The FDA has assigned a Prescription Drug User Fee Act of Dec. 20, 2024, for Zynquista (sotagliflozin) to control glycemic levels in adults with type 1 diabetes and chronic kidney disease.

The FDA identified at a third party fill and finish manufacturer. The issues have been resolved, and reinspection is expected in the next few months.

This therapy is a first-in-class treatment for chronic graft-versus-host disease, which develops in roughly 42% of those who receive a stem cell of bone marrow transplant.

Livdelz is an oral therapy to treat patients with primary biliary cholangitis, a progressive autoimmune disease. It is expected to be available in pharmacies next week.

This first-in-class treatment targets multiple disease mechanisms such as itch and inflammation associated with this condition.

Enzeevu is biosimilar to Eylea (aflibercept), which was FDA-approved in 2019.

Crexont kept symptoms at bay for an extra 30 minutes a day when compared with other Parkinson’s drugs.

Zunveyl, a prodrug of galantamine that addresses the gastrointestinal side effects, will be available in the first quarter of 2025.

Leqselvi is approved to treat adults with severe alopecia. One-third of patients in clinical trials experienced 80% scalp hair coverage at 24 weeks.

Duvyzat was approved in March 2024 and works to reduce the inflammation and loss of muscle experienced by patients with Duchenne muscular dystrophy.

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

If approved, tabelecleucel would be the first therapy specifically to treat Epstein-Barr virus related post-transplant lymphoproliferative disease. The FDA’s action date is Jan. 15, 2025.

OX124 is a nasal spray provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA would like to see additional technical data, as well as data on whether patients can correctly use the device.

Giant cell arteritis is an inflammatory disease that affects the large blood vessels that supply blood to the head and brain.

The FDA is asking for information about the manufacturing process, as well as the type 1 diabetes indication.

Genentech had recalled the Susvimo ocular implant two years ago. The FDA has approved changes to the implant and needle.

The prefilled syringe of Vabysmo will become available in the coming months. It treats age-related macular degeneration, diabetic macular edema and macular edema following retinal vein occlusion.

Donanemab — now with the brand name of Kisunla — slows cognitive and functional decline by up to 35% and has a list price of $695.65 per vial.

Samsung Bioepis’ Pyzchiva (ustekinumab-ttwe) will be available beginning Feb. 22, 2025 and will be marketed by Sandoz.

For the second time, the FDA is asking for additional information about chemistry manufacturing and controls.

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.