Browsing Tag
Breakthrough Therapy Designation
7 posts
Dizal’s sunvozertinib beats chemo in phase 3 first-line NSCLC trial, opening path to new drug applications
Dizal's sunvozertinib beats platinum chemo in WU-KONG28 phase 3 first-line EGFR exon 20 NSCLC trial. What this means for patients, rivals and investors. Read more.
Two years in, is Lundbeck’s bexicaserin redefining how we treat drug-resistant seizures?
Lundbeck’s bexicaserin shows two-year seizure control in rare epilepsies. Explore how the durable data could redefine drug development in childhood DEEs.
GSK secures FDA breakthrough therapy designation for GSK5764227 in lung cancer treatment
GSK plc (LSE/NYSE: GSK) has announced a significant milestone in its oncology program, with the US Food and…
Brii Biosciences receives breakthrough therapy designations for HBV treatments
Brii Biosciences Limited, a biotechnology company developing therapies for diseases with high unmet need, announced that the Center…
Amgen secures breakthrough therapy designation for sotorasib in China
Amgen has achieved a major milestone in the global development of its investigational KRAS G12C inhibitor, sotorasib, with…
Eli Lilly completes $8bn acquisition of Loxo Oncology to expand oncology portfolio
Eli Lilly and Company, the US-based pharmaceutical giant, has finalised its $8 billion acquisition of Connecticut-based biopharmaceutical firm…
FDA accelerates review of Novartis’s Zykadia for first-line treatment in lung cancer
Novartis AG, a prominent Swiss pharmaceutical company, has received a significant regulatory boost as its lung cancer medication,…