An application from GSK to increase the use of its very effective RSV vaccine, Arexvy, has been formally approved by the U.S. Food and Drug [Read More…]
Novo Nordisk has applied to the European Medicines Agency (EMA) for a new, increased dosage of Wegovy® (semaglutide), a well-known medication for weight loss, of [Read More…]
The European Commission has approved AstraZeneca’s Imfinzi, establishing a new standard of care for muscle-invasive bladder cancer. This landmark decision makes Imfinzi the first perioperative immunotherapy available to patients in the EU, following a pivotal Phase III trial where the regimen significantly reduced the risk of cancer recurrence and death. This approval marks a transformative moment for patients with this high-risk disease.
Amgen has announced positive topline results from the Phase 3 FIGHT trial evaluating bemarituzumab in combination with chemotherapy for advanced gastric and gastroesophageal junction (GEJ) cancer.
Pfizer announces its hemophilia drug HYMPAVZI™ significantly reduced annualized bleeding rates in its Phase 3 BASIS study for patients with inhibitors.
Novo Nordisk announced that its leading diabetes medication, Ozempic® (semaglutide), has received a positive recommendation in the EU for an updated label to include peripheral arterial disease.
Amgen presented Phase 2 data showing that its investigational obesity therapy, maritide, administered monthly, led to significant weight loss in adults with obesity or overweight. The treatment was generally well tolerated, supporting further clinical development.
Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of STELARA® (ustekinumab) [Read More…]
Swiss healthcare giant Roche is advancing prasinezumab, a potential first-in-class anti-alpha-synuclein antibody for early Parkinson’s disease, into Phase III trials. This decision follows encouraging data from the Phase IIb PADOVA study and its long-term follow-up, suggesting the drug offers clinical benefits.
Johnson & Johnson reported encouraging new results from a Phase 1b trial that found its experimental oral medicine, bleximenib, given with the routine treatment regimen [Read More…]
