Eli Lilly has officially received Foundayo FDA approval for orforglipron, the first daily non-peptide oral GLP-1 receptor agonist that offers significant weight loss results without the dietary restrictions of previous oral treatments.
GSK has secured the Exdensur depemokimab China approval from the NMPA, introducing the first respiratory biologic with a twice-yearly dosing regimen for patients with severe eosinophilic asthma.
GSK’s risvutatug rezetecan has officially secured Orphan Drug Designation from Japan’s MHLW for the treatment of small-cell lung cancer (SCLC). Supported by durable response data from the ARTEMIS-001 trial, this B7-H3-targeted antibody-drug conjugate aims to transform the prognosis for patients with extensive-stage disease, who currently face a median survival of just 8 months. This marks the sixth major global regulatory designation for risvutatug rezetecan, signaling its critical role in the future of oncology.
ohnson & Johnson has announced FDA approval of ICOTYDE (icotrokinra), the first and only IL-23R targeted oral peptide designed for first-line systemic treatment of moderate-to-severe plaque psoriasis. This groundbreaking approval represents a paradigm shift in dermatology, offering patients unprecedented efficacy with complete skin clearance in over 70% of clinical trial participants.
FDA warning letter reveals systemic failures in Novo Nordisk’s semaglutide safety reporting. Details on 15-day reporting violations, deaths, and suicides not reported to FDA. Regulatory analysis and consequences.
osentyx FDA approval marks first IL-17A inhibitor for pediatric patients 12+ with hidradenitis suppurativa. Discover how this breakthrough treatment transforms care for adolescents facing HS.
Johnson & Johnson secures EC approval for AKEEGA® as the first precision-medicine combo for BRCA1/2-mutated metastatic hormone-sensitive prostate cancer, supported by landmark rPFS data from the AMPLITUDE trial.
Johnson & Johnson announced FDA approval of TECVAYLI plus DARZALEX FASPRO for relapsed/refractory multiple myeloma with unprecedented clinical data demonstrating significant improvements in progression-free survival and overall survival.
Johnson & Johnson announces FDA Fast Track designation for nipocalimab in systemic lupus erythematosus. The immunoselective therapy demonstrated reduction in lupus disease activity in Phase 2 JASMINE study, offering potential steroid-sparing benefits and accelerated FDA review timeline.
The FDA has approved PADCEV (enfortumab vedotin) in combination with Keytruda (pembrolizumab) as the first perioperative treatment regimen to significantly improve survival in cisplatin-ineligible patients with muscle-invasive bladder cancer. Based on pivotal Phase 3 EV-303 trial data, the combination demonstrated a 60% reduction in recurrence or death risk and a 50% reduction in mortality risk compared to surgery alone.
