GSK’s B7-H3-targeted antibody-drug conjugate, Risvutatug Rezetecan, has been granted Orphan Drug Designation by the US FDA for small-cell lung cancer (SCLC), based on promising early clinical data.
Eli Lilly announced that its non-covalent BTK inhibitor, Jaypirca (pirtobrutinib), met the primary endpoint of non-inferiority on Overall Response Rate (ORR) when compared to Imbruvica (ibrutinib) in the landmark BRUIN CLL-314 Phase 3 trial. The drug demonstrated numerically higher efficacy (87.0% ORR) and a significant safety advantage, including much lower rates of atrial fibrillation/flutter and hypertension, positioning Jaypirca as a potential new front-line therapy for CLL/SLL.
CARVYKTI demonstrated lasting treatment-free remissions at 2.5 years in standard-risk Multiple Myeloma patients treated as early as first relapse in the CARTITUDE-4 study.
Biomoneta is the first Indian health-tech firm to receive US-FDA Class II clearance for its Avata Rx Medical Air Cleaner, which uses patented ZeBox technology for >99.9999 pathogen elimination.
U.S. FDA has granted full approval to Eli Lilly’s Jaypirca (pirtobrutinib) for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This expanded indication allows the use of the non-covalent BTK inhibitor immediately following prior covalent BTK inhibitor therapy. The decision is bolstered by data from the Phase 3 BRUIN CLL-321 trial, which demonstrated a statistically significant improvement in progression-free survival compared to standard combinatorial therapies.
Johnson & Johnson has secured European Commission approval for Imaavy (nipocalimab), a novel treatment for generalized myasthenia gravis (gMG). This authorization marks the first FcRn blocker approved in Europe for a broad population that includes both adults and adolescents (aged 12+), offering a new option for sustained disease control.
In a major move to improve affordability and counter the compounded drug market, Eli Lilly has cut the monthly cost of Zepbound to $299 for the starter dose. Available exclusively through LillyDirect, these new single-dose vials offer a significant discount for patients without insurance coverage. Read the full details on the new pricing structure and how it impacts the weight-loss drug market.
Novartis has secured FDA approval for Itvisma (onasemnogene abeparvovec-brve), marking a historic milestone as the first gene replacement therapy for spinal muscular atrophy (SMA) available to children aged two and older, teens, and adults. This one-time intrathecal injection offers a “game-changing” new treatment option for patients previously ineligible for gene therapy.
Novo Nordisk has officially filed for FDA approval of a higher, 7.2 mg dose of the weight-loss drug Wegovy®. Submitted under the expedited CNPV program, the new dose promises an accelerated review timeline. Phase 3 trial results indicate the 7.2 mg injection could offer significantly greater weight loss potential than the current standard dose.
Novo Nordisk has announced positive headline results from a Phase 2 clinical trial for its investigational drug, amycretin, showcasing its potential to be a next-generation [Read More…]
