Gillian McGovern, Associate Editor

This decision is believed to redefine how biological drugs will be developed, approved, and made affordable for patients.

The approval of 2 denosumab biosimilars, Bildyos and Bilprevda, enhances access to affordable bone health treatments for patients.

The subcutaneous injection for maintenance treatment enhances accessibility and reduces infusion time for patients.

Future research should focus on optimizing drug design, mitochondrial biogenesis regulation, and establishment of treatments for acute kidney injury (AKI).

The action is supported by 3 ongoing clinical trials, which are evaluating izalontamab brengitecan (iza-bren) in non–small cell lung cancer (NSCLC) and other diseases.

The FDA updated sparsentan's REMS, easing monitoring requirements, enhancing treatment access for IgA nephropathy patients, and supporting kidney function preservation.

Biosimilars can be a more affordable and accessible treatment option for patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA).

Oral selective estrogen receptor degraders (SERDs) are a promising line of treatments for patients with breast cancer.

The action is significant for patients with extensive-stage small cell lung cancer (SCLC), a population with limited treatment options.

If long-term efficacy results are positive, metformin can become an accessible, affordable treatment option for autosomal dominant polycystic kidney disease (ADPKD).

When treating patients with bone metastases, the biosimilar demonstrated equivalent safety and efficacy to its reference product.

A new biosimilar, LY05008, shows comparable efficacy and safety to dulaglutide in managing type 2 diabetes mellitus (T2DM) in Chinese adults.

New research confirms that switching from tocilizumab to its biosimilar, Avtozma, maintains efficacy and safety in patients with rheumatoid arthritis (RA).

Both preclinical and translational evidence support MET inhibition as a therapeutic approach in patients with small cell lung cancer (SCLC).

The complete response letter (CRL) stated that vatiquinone's new drug application (NDA) did not provide substantial evidence of efficacy and would need to be evaluated in a new trial.

Unicycive Therapeutics secures a US patent for UNI-494, a promising treatment for chronic kidney disease, enhancing its development and partnership potential.

FDA approves Tonmya, the first new fibromyalgia treatment in 15 years, offering hope for effective pain relief and improved quality of life.

The designation is supported by promising results from the ongoing phase 1/2 BEACON clinical trial.

New research links high perilipin 2 expression in lung adenocarcinoma to aggressive disease progression and shorter survival, highlighting potential treatment targets.

New research reveals that novel biomarkers enhance risk prediction for kidney failure and mortality in chronic kidney disease (CKD), paving the way for personalized treatment.

Pharmacists help connect patients with the correct resources and help remove barriers so patients can receive continuous care.

Pharmacists can educate patients and health care professionals in addition to coordinating lab orders, interpreting results, and guiding patients through the next steps.

The action follows 2 FDA-issued complete response letters.

Jennifer Goldman, PharmD, CDCES, BC-ADM, FCCP, explains the different stages of type 1 diabetes, teplizumab’s use, and emphasizes the pharmacist’s role in care.

Discover effective strategies for managing obesity to enhance cardiovascular health, including innovative treatments and the vital role of pharmacists.

The researchers speculate that this is because of the antioxidant and anti-inflammatory properties of coffee and tea.

Recent data link a higher consumption of ultraprocessed food to increased lung cancer risk, highlighting the need for dietary changes and further research.

The FDA approved fremanezumab for pediatric migraine prevention, offering a new treatment option for children and adolescents aged 6 to 17 years.

Herzuma shows promising efficacy and safety as a cost-effective biosimilar for treating HER2+ advanced gastric cancer, offering new hope for patients.

The FDA approves aceclidine ophthalmic solution 1.44%, the first aceclidine eye drop for presbyopia, offering a new solution for millions struggling with near vision loss.