FDA

Prademagene zamikeracel (pz-cel) could be a new treatment for rare genetic disease recessive dystrophic epidermolysis bullosa (RDEB).

This week’s approval expands Seldardsi indications to treat adults with Crohn’s disease and ulcerative colitis.

Zolbetuximab — now with the brand name Vyloy — is a monoclonal antibody to treat patients with advanced gastric and gastroesophageal cancers.

Imuldose will be marketed in the United States by Accord BioPharma and is expected to launch in the first half of 2025.

Hympavzi is the first anti-tissue factor pathway inhibitor approved in the United States for hemophilia.

Itovebi is approved to treat patients with PIK3CA-mutated HR-positive, HER2 negative metastatic breast cancer in combination with Ibrance and fulvestrant. It will have a cost of $22,867 for a 28-day cycle.

If approved, elinzanetant would be another non-hormonal option for menopausal women seeking hot flash relief.

Dry eye disease affects up to 15% of the U.S. population and is one of the largest markets in the ophthalmology field.

Otulfi is the fourth Stelara biosimilar to be approved by the FDA.

This is the sixth indication for Dupixent and the only biologic approved in the United States to treat COPD.

KarXT — now with the brand name Cobenfy— is expected to be available in October with a list price of about $22,500 annually. The drug represents a new way to treat adults with schizophrenia.

Aqneursa is the second drug approved within a week to treat Niemann-Pick Disease, Type C.

The FDA has already approved Zoryve cream (0.3% and 0.15%) for plaque psoriasis and atopic dermatitis in adults and children ages 6 and up. Currently, Zoryve foam 0.3% is only approved to treat seborrheic dermatitis in adult and pediatric patients 9 years and older.

This is the first FDA approved medication for the rare and progressive neurodegenerative disease, Niemann-Pick Disease Type C.

Bimzelx was first approved last year for the treatment of moderate to severe psoriasis in adults, making it the first and only IL-17A and IL-17F inhibitor approved in the United States for four autoimmune diseases.

Today’s approval means that FluMist is the first pharmacy-prescribed influenza vaccine that does not need to be given by a healthcare professional.

More than half (60%) of patients in latest trial reached active remission and 41% stopped taking corticosteroid entirely.

This new, first-line biologic treatment provided symptom relief for patients for up to one year.

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.