In a randomized crossover clinical trial (NCT05263232), Harmsen et al. investigated the metabolic effects of natural daylight exposure during office hours in individuals with type 2 diabetes (T2D). Thirteen participants with T2D, virologically suppressed on treatment, were exposed to either natural daylight (facilitated through windows) or constant artificial office lighting for 4.5 consecutive days in a controlled setting, with interventions separated by a washout period.
GSK announced on January 7, 2026, positive topline results from the two pivotal Phase III trials, B-Well 1 (NCT05630807) and B-Well 2 (NCT05630820), evaluating bepirovirsen, an investigational triple-action antisense oligonucleotide (ASO), as a potential first-in-class finite treatment for chronic hepatitis B (CHB).
On December 12, 2025, the U.S. Food and Drug Administration (FDA) granted approval for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) in combination with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). This supplemental New Drug Application (sNDA) approval marks AKEEGA as the first and only precision medicine combination of a PARP inhibitor and androgen receptor pathway inhibitor specifically indicated for BRCA2-mutated mCSPC, expanding its prior 2023 approval for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).
Muscle-invasive bladder cancer (MIBC) represents approximately 30% of the ~614,000 annual global bladder cancer cases, ranking it as the ninth most common malignancy worldwide. While neoadjuvant cisplatin-based chemotherapy followed by cystectomy remains the standard for eligible patients, up to half of those with MIBC are ineligible for cisplatin due to comorbidities, renal impairment, or other factors, leaving them with limited perioperative options and high recurrence rates—nearly 50% even post-surgery. On November 21, 2025, the U.S. Food and Drug Administration (FDA) approved a transformative regimen: PADCEV® (enfortumab vedotin-ejfv), a Nectin-4-directed antibody-drug conjugate (ADC), in combination with Keytruda® (pembrolizumab) or Keytruda QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), for neoadjuvant treatment followed by adjuvant therapy post-cystectomy in cisplatin-ineligible adults with MIBC.
On October 8, 2025, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved Libtayo (cemiplimab-rwlc), a PD-1 inhibitor, as the first and only immunotherapy for adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence following surgery and radiation. This approval, evaluated under Priority Review, is grounded in data from the pivotal Phase 3 C-POST trial, published in the New England Journal of Medicine and presented at ASCO 2025.
Extensive-stage small cell lung cancer (ES-SCLC) is an aggressive malignancy with a poor prognosis, where first-line induction therapy typically involves platinum-etoposide chemotherapy combined with immunotherapy like atezolizumab, followed by maintenance to delay progression. Despite advances, relapse rates remain high, underscoring the need for effective maintenance strategies. On October 2, 2025, the U.S. Food and Drug Administration (FDA) approved lurbinectedin (Zepzelca), an alkylating agent that binds DNA guanine residues to disrupt the cell cycle and induce cancer cell death, in combination with atezolizumab (Tecentriq), a PD-L1 inhibitor, or its subcutaneous form (Tecentriq Hybreza), as first-line maintenance therapy for adult patients with ES-SCLC whose disease has not progressed after four cycles of induction therapy with atezolizumab, carboplatin, and etoposide. This approval, the first for a combination maintenance regimen in this setting, was based on the phase 3 IMforte trial (NCT05091567), a randomized, open-label, multicenter study involving 483 patients across 13 countries.
