Product Approvals and Launches

After FDA approval, XDEMVY is available for prescription nationwide to target Demodex mites, the primary cause of the external eye disease Demodex blepharitis.

This approval marks the fourth endorsement by the FDA for empagliflozin, all of which have been linked to the EMPOWER program.

Javed Butler, MD, MPH, MBA, professor of medicine at University of Mississippi, president of the Baylor Scott & White Research Institute, explains how findings from the HEART-FID trial add to the value of ferric carboxymaltose injection.

Trials such as HEART-FID and AFFIRM-AHF have demonstrated positive treatment results for injectable ferric carboxymaltose in patients with heart failure and iron deficiency.

The agency's approval of momelotinib marks the first for both newly diagnosed and previously treated myelofibrosis with anemia.

The combination therapy is the first FDA approved for the mobilization of hematopoietic stem cells prior to autologous transplantation in patients with multiple myeloma.

The FDA approved a higher dosage of aflibercept (Eylea) for the treatment of age-related macular degeneration, macular edema, and diabetic retinopathy.

The FDA has approved the first biosimilar to treat multiple sclerosis, Sandoz's injection treatment natalizumab-sztn (Tyruko).

The respiratory syncytial virus (RSV) vaccine Abrysvo is approved for use in pregnant individuals to prevent RSV in infants up to 6 months of age.

The targeted therapy already has indications in acute myeloid leukemia.

The FDA has granted accelerated approval to elranatamab-bcmm (Elrexfio) for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Patients with relapsed/refractory multiple myeloma may now receive talquetamab following the agent’s accelerated approval by the FDA.

The FDA approved trifluridine and tipiracil (Lonsurf) plus bevacizumab (Avastin) for patients with metastatic colorectal cancer who had previously been treated based on data from the phase 3 SUNLIGHT trial.

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).

Tycel Phillips, MD, hematologist-oncologist at City of Hope in Duarte, CA, discussed the utility of epcoritamab in diffuse large B-cell lymphoma (DLBCL) and the potential impacts the bispecific antibody's recent approval will have in the community oncology setting.

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.