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.
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.
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
Pfizer announced positive progression-free survival results from BREAKWATER trial Cohort 3, showing BRAFTOVI combined with cetuximab and FOLFIRI achieves statistically significant and clinically meaningful progression-free survival improvement compared to chemotherapy alone in previously untreated BRAF V600E-mutant metastatic colorectal cancer patients.
FDA approves a new simplified monthly dosing schedule for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in combination with LAZCLUZE (lazertinib) for first-line treatment of EGFR-mutated advanced non-small cell lung cancer. The approval allows patients to transition to monthly injections as early as Week 5, significantly reducing clinic visits while maintaining consistent efficacy with the previously approved bi-weekly schedule. PALOMA-2 trial data demonstrated high objective response rates and a fivefold reduction in administration-related reactions compared to intravenous delivery.
Eli Lilly has entered a $2.4 billion definitive agreement to acquire Orna Therapeutics. This strategic move integrates Orna’s proprietary circular RNA platform and in vivo CAR-T pipeline into Lilly’s growing portfolio, signaling a major shift toward more accessible and scalable genetic medicines for B cell-driven autoimmune diseases.
A landmark real-world analysis revealed that patients with metastatic castration-sensitive prostate cancer (mCSPC) treated with Erleada® (apalutamide) saw a 51% lower risk of death compared to those treated with darolutamide. This data marks a significant breakthrough for patients seeking effective, “chemo-free” treatment options.
Johnson & Johnson announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending [Read More…]
In a landmark development for personalized medicine, Moderna, Inc. and Merck (known as MSD outside the U.S. and Canada) announced today that their investigational mRNA-based [Read More…]
