The PDUFA action date for an FDA decision for linvoseltamab to treat adult patients with relapsed/refractory multiple myeloma is July 10, 2025.
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Emblaveo will be available in the third quarter of 2025 to treat patients with intra-abdominal infections, a common cause of sepsis in the intensive care unit.
Regulators have set a goal of Aug. 12, 2025, for brensocatib to treat patients with non-cystic fibrosis bronchiectasis, a chronic lung disease.
Susvimo is also approved to treat age-related macular degeneration, and the medication, ranibizumab, is delivered though a refillable ocular implant.
The new biosimilar, Celltrion’s Avtozma, was approved in both IV and subcutaneous forms to treat inflammatory conditions such as arthritis.
Chronic kidney disease affects about 37 million adults in the United States and is expected to rise. It is a common complication of type 2 diabetes.
A monthly 10 mg/mL maintenance dose of Leqembi had the same effects on mild Alzheimer’s symptoms as biweekly dose, research shows.
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower FDA-approved dosage.
Regulatory officials have identified 82 cases worldwide from the FDA Adverse Event Reporting System of anaphylaxis associated with the use of Coxapone and the generic Glatopa that have resulted in hospitalization or death.
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The investigational advanced melanoma combination therapy consisting of RP1 and nivolumab have a PDUFA action date of July 22, 2025.
Trump has reversed some of President Biden’s initiatives, including $2 monthly out-of-pocket cap on some generics and experimental pricing models for gene therapies. But so far the healthcare elements of the Inflation Reduction Act remain unchanged.
Datroway reduced disease progression by 37% when compared with chemotherapy.
CEO Andrew Witty promised that UnitedHealthcare would work to speed up turnaround times for approval of some procedures and services in Medicare Advantage plans.
Ozempic, Rybelsus and Wegovy top the list of the newest drugs selected for Medicare Part D price negotiation, part of the Inflation Reduction Act.
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.
In an investor call, Andrew Witty promised full transparency and 100% pass-through rebates for prescription drugs by 2028.
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 Federal Trade Commission suggests that PBMs profit from specialty generic drugs such as those for cancer and HIV and steer patients to their own pharmacies.
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.
Regulators say, however, the benefits of vaccination with Abrysvo and Arexvy in preventing respiratory syncytial virus continue to outweigh their risks.
Effective Jan. 1, 2025, Independence Blue Cross has begun excluding coverage for 18 months for therapies — but not cancer drugs — that have an accelerated approval based on a surrogate endpoint.
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.
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