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.
Pfizer announced FDA full approval of BRAFTOVI (encorafenib) in combination with cetuximab and fluorouracil-based chemotherapy for treating adults with BRAF V600E-mutant metastatic colorectal cancer. The landmark approval is backed by Phase 3 BREAKWATER trial data demonstrating a 51% reduction in mortality risk and 47% reduction in disease progression risk compared to standard chemotherapy.
Eli Lilly expands Zepbound access with FDA-approved KwikPen multi-dose device. Patients can now choose between KwikPen or single-dose vials at the same price through LillyDirect, with self-pay pricing offering 50% or greater discount compared to other GLP-1 medicines.
On February 20, 2026, the U.S. FDA approved the combination of Venclexta (venetoclax) and acalabrutinib for the first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This landmark decision establishes the first and only all-oral, fixed-duration (time-limited) regimen for previously untreated patients, offering a significant alternative to continuous therapy or chemoimmunotherapy
European Commission approves Wegovy 7.2 mg for obesity treatment. Clinical trial shows 21% average weight loss with 84% from fat mass. Now available across EU.
