FDA

The FDA has approved UCB's Bimzelx for moderate-to-severe hidradenitis suppurativa, offering a new treatment option for this painful autoimmune skin disease.

Relapsed or refractory acute leukemia with a KMT2A translocation currently has an overall survival rate of less than one year when treated with frontline therapies.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of April 2, 2025, for reproxalap for patients with dry eye disease. Reproxalap also is being tested in allergic conjunctivitis.

The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic spontaneous urticaria, an inflammatory skin disease.

After feedback from the FDA, the companies have voluntarily withdrawn the previous biologics licensing application for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous non-small cell lung cancer.

Aucatzyl is a CAR T-cell therapy that targets CD19 and has been designed to minimize excessive activation of the programmed T cells. The wholesale acquisition cost is $525,000

An FDA advisory committee last year agreed that the data do not support phenylephrine as an effective nasal decongestant.

If approved, donidalorsen would be a first-in-class RNA-targeted medicine for hereditary angioedema. The agency’s goal date is August 21, 2025.

Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic levels in adults with type 1 diabetes and chronic kidney disease. The agency’s goal date is Dec. 20, 2024.

Scemblix (asciminib) is a new first-line option for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).

Regulators are also reviewing Teva’s application for its Prolia biosimilar candidate. The FDA’s decisions are expected mid-year 2025.

PTC Therapeutics' NDA resubmission of Translarna was based on data from Study 041 and the long-term STRIDE registry. No PDUFA action date was provided for regulators.

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.