News &amp; Updates

The investigational allogeneic cell therapy deramiocel helps mitigate the progression of upper limb disease in young patients with Duchenne muscular dystrophy (DMD), as shown in the pivotal phase 3 HOPE-3 study.

Novel cellular therapy delays upper limb decline in DMD

First-line capivasertib-paclitaxel therapy misses survival target in metastatic TNBC

Combination treatment with capivasertib and paclitaxel falls short of prolonging overall survival (OS) compared with placebo plus paclitaxel in patients with metastatic triple-negative breast cancer (TNBC), either in the overall or PIK3CA/AKT1/PTEN-altered populations, as shown in the CAPItello-290 trial

First-line capivasertib-paclitaxel therapy misses survival target in metastatic TNBC

12 May 2026

Auranofin-sirolimus combo delivers no antineoplastic activity in recurrent ovarian cancer

Inhibition of the protein kinase C iota (PKCι) with auranofin and sirolimus does not provide antineoplastic effects in patients with recurrent high-grade serous ovarian cancer, reports a phase II study.

Auranofin-sirolimus combo delivers no antineoplastic activity in recurrent ovarian cancer

Perioperative adebrelimab plus chemo: A new Tx option for resectable NSCLC?

Perioperative adebrelimab plus chemotherapy improves event-free survival (EFS) and major pathological response (MPR) in individuals with resectable stage II/III non-small cell lung cancer (NSCLC) in an interim analysis.

Perioperative adebrelimab plus chemo: A new Tx option for resectable NSCLC?

12 May 2026

High-dose influenza vaccination reduces hospitalizations in older adults

High-dose influenza vaccination is associated with a reduced risk of hospitalization for pneumonia or influenza in older adults, regardless of immunosuppression status, according to a prespecified pooled analysis of the FLUNITY-HD study presented at ESCMID Global 2026.

High-dose influenza vaccination reduces hospitalizations in older adults

Nitrofurantoin prevails in antibiotic showdown for uncomplicated UTI in women

11 May 2026 by

Nitrofurantoin performs better than single-dose fosfomycin in the treatment of uncomplicated urinary tract infections (UTIs) in women in the primary care setting, according to the SCOUT trial.

Nitrofurantoin prevails in antibiotic showdown for uncomplicated UTI in women

Immunotherapy improves survival in ES-SCLC in first-line setting

First-line treatment with immune checkpoint inhibitors (ICIs) is safe and effective in patients with extended stage (ES) small-cell lung cancer (SCLC), but its use as second-line agent is not recommended, according to a study.

Immunotherapy improves survival in ES-SCLC in first-line setting

Tebentafusp a ray of hope in rare eye cancer

11 May 2026 by

The 5-year data from the phase III IMCgp100-202 study demonstrate durable, long-term overall survival (OS) benefit with the novel agent tebentafusp—a first-in-class, bispecific, soluble T-cell receptor (TCR) therapeutic—in individuals with previously untreated metastatic uveal melanoma (UM).

Tebentafusp a ray of hope in rare eye cancer

Original New Drug Application Approvals by US FDA (16-30 April 2026)

New drug applications approved by US FDA as of 16-30 April 2026 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (16-30 April 2026)