Product Approvals and Launches

Beyfortus, which can help prevent respiratory syncytial virus (RSV) in infants and toddlers, was approved by the FDA on July 17.

The FDA has approved the first over the counter (OTC) birth control pill Thursday; the US Chamber of Commerce has filed a motion for preliminary injunction on the Medicare Drug Price Negotiation program; individuals living in historically redlined areas are likely to have worse heart health.

The full approval follows an accelerated approval from January 2023 and was based on a confirmatory trial, which found lecanemab slowed disease progression compared with placebo.

The act was passed in 1983 and has contributed to increased research and development on treatments for rare diseases.

Approximately 2500 individuals in the United States could be eligible to receive valoctocogene roxaparvovec.

The treatment is the first approved by the FDA to treat the 2 most common subtypes of generalized myasthenia gravis.

The therapy, to be marketed as Elevidys, is approved for the treatment of ambulatory pediatric patients aged 4 through 5 years with DMD who have a confirmed mutation in the DMD gene.

Talazoparib in combination with enzalutamide showed a 55% reduction in the risk of disease progression or death for patients with metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) gene mutations in the phase 3 TALAPRO-2 trial.

Glofitamab is the first bispecific antibody with a fixed-duration treatment for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The FDA approved Pfizer’s respiratory syncytial virus (RSV) vaccine Wednesday; Medicare announced plans to largely cover a new class of expensive Alzheimer drugs; more states are extending postpartum coverage under Medicaid.

Olaparib plus abiraterone and prednisone or prednisolone already is approved in the European Union and several other countries.

Lexicon Pharmaceuticals received approval for sotagliflozin to treat a broad range of left ventricular ejection fraction, for patients with and without diabetes.

Christopher P. Cannon, MD, a professor of medicine at Harvard Medical School and senior physician in the Cardiovascular Division at Brigham and Women’s Hospital, spoke about the benefit seen in a study of sotagliflozin for patients with acute heart failure.

The FDA approves Pfizer’s oral COVID-19 drug; hundreds of thousands of people lose Medicaid coverage after pandemic protections expire; irregular menstrual cycles seem to be linked with higher cardiovascular disease (CVD) risks.

The FDA approved Celltrion Healthcare’s Yuflyma (adalimumab-aaty), which is a high-concentration, citrate-free formulation.

Approval for the T-cell–engaging bispecific antibody came today from the FDA.

Just over a year since AstraZeneca announced topline results, the FDA has approved a label expansion to include reducing cardiovascular (CV) death and heart failure–related hospitalizations for dapagliflozin (Farxiga) based on results of the phase 3 DELIVER trial.

A vaccine for adults 60 years and older was approved by the FDA for protection against respiratory syncytial virus, making it the first such vaccine to be approved worldwide.

The FDA has approved polatuzumab vedotin-piiq plus rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for certain patients with treatment-naive diffuse large B-cell lymphoma.

The FDA has granted accelerated approval to enfortumab vedotin-ejfv plus pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

Data from the PANORAMA-HF and PARADIGM-HF trials support the recommendation for approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

The FDA has granted full approval to pembrolizumab for the treatment of some patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) solid tumors that have progressed following previous treatment.

Both the high-concentration and low-concentration versions of adalimumab-adaz (Hyrimoz) injection will launch in July, along with a wave of other biosimilars to Humira (reference adalimumab).

Sarilumab, a biologic, is sold as Kevzara.

The FDA approved the VENTANA PD-L1 assay for expanded use in patients with advanced non–small-cell lung cancer to help identify patients who may be candidates for treatment with cemiplimab.

The FDA approved an expanded indication for abemaciclib (Verzenio) in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)–positive, HER2-negative, node-positive, early breast cancer that is at a high risk of recurrence.

Pegcetacoplan was approved by the FDA to treat geographic atrophy (GA), providing a treatment option for patients who previously had none, explained Eleonora Lad, MD, PhD, associate professor of ophthalmology, Duke University.