FDA

The investigational advanced melanoma combination therapy consisting of RP1 and nivolumab have a PDUFA action date of July 22, 2025.

One-third of folks with major depressive disorder experience treatment-resistant depression (TRD), a condition that makes it more difficult to be treated by traditional oral antidepressants.

Datroway reduced disease progression by 37% when compared with chemotherapy.

More than half (53%) of patients reached remission after one year of Omvoh treatment and 46% experienced healing of the intestinal tract, when compared to placebo.

If approved, subcutaneous autoinjector Leqembi will be the only Alzheimer's medication that can be administered at home. The FDA has set a goal date of Aug. 31, 2025.

The target action date for Rexulti in combination with sertraline to treat patients with post-traumatic stress disorder, originally planned for Feb. 8, 2025, will be delayed.

Kerenida is currently approved to slow the progression of chronic kidney disease associated with type 2 diabetes.

Gastric cancer, commonly known as stomach cancer, is the fifth most common cancer globally and the fifth leading cause of cancer-related deaths.

Deramiocel is a cell therapy that has healing effects in muscle cells. If approved, deramiocel would be a once-quarterly therapy and the first specifically approved for cardiomyopathy in patients with Duchenne muscular dystrophy.

FDA officials have set a review date of June 30, 2025, to review avutometinib in combination with defactinib to treat patients with recurrent low-grade serous ovarian cancer.

In November 2024, a regulatory advisory board said the benefits of Zynquista does not outweigh the risks in adults with type 1 diabetes and chronic kidney disease.

Opdivo Qvantig is the first subcutaneously administered PD-1 inhibitor approved by the FDA. It is expected to be available in early January 2025 and will be priced at parity to the IV version of Opdivo.

Liraglutide injection is now approved for adult and pediatric patients ages 10 and up, proving another option amid the GLP-1 shortage.

Up to half of obstructive sleep apnea patients taking Zepbound had no symptoms after one year of treatment, averaging 25 fewer breathing interruptions per hour.

If approved, Molbreevi could be the first FDA-approved treatment for patients with autoimmune pulmonary alveolar proteinosis, a rare lung disease.

Tryngolza is once-monthly, subcutaneous RNA-targeted therapy and is expected to be available by the end of the year with a price of $595,000.

Originally approved in 2009, Stelara patents began expiring in 2023, leading to an influx of recent biosimilars.

If approved, clesrovimab would be the first and only FDA approved single dose immunization for infants approved in time for next year's RSV season, which lasts from October to April.

This latest approval is the second indication of the monoclonal antibody, Nemluvio. It was first approved in Aug. 2024 to treat patients with prurigo nodularis.

The combination of Columvi, gemcitabine and oxaliplatin is the first CD20xCD3 bispecific antibody to show positive results in a randomized diffuse large B-cell lymphoma phase 3 trial. The FDA’s decision is expected by July 20, 2025.

The FDA has accepted a new drug application for aficamten, a new obstructive hypertrophic cardiomyopathy drug. A goal date has been set for Sept. 26, 2025.

Yesintek is the latest Stelara biosimilar to gain FDA approval and it will be available in February 2025.

If granted, Tremfya will be approved to treat children ages six and under with severe plaque psoriasis and children ages five and under with juvenile psoriatic arthritis.

Vutrisiran is the generic form of previously approved Amvuttra. The FDA’s target date for the treatment of transthyretin amyloidosis with cardiomyopathy is March 23, 2025.

Imkeldi is a new formulation of imatinib approved as a strawberry-flavored, shelf-stable liquid designed to be more appealing to a wider range of patients, pediatric patients included.

Attruby (acoramidis) is a small molecule approved to treat adults with transthyretin amyloid cardiomyopathy. It will have a list price of $18,759 for a month’s supply.

Produced in Chinese hamster ovary cells, Ziihera (zanidatamab-hrii) is the first HER2-targeted bispecific antibody treatment for patients with previously treated, unresectable or metastatic biliary tract cancer.

After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.

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.