GSK plc (LSE/NYSE: GSK) has announced a significant milestone in its oncology program, with the US Food and Drug Administration (FDA) granting Breakthrough Therapy Designation for its investigational drug GSK5764227 (GSK’227). This designation, aimed at expediting the development and review of drugs that could offer substantial improvements over existing therapies, underscores the potential of GSK’227 […]
Brii Biosciences Limited, a biotechnology company developing therapies for diseases with high unmet need, announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designations for BRII-877 (tobevibart) and BRII-835 (elebsiran). These investigational therapies target the hepatitis B virus (HBV) and are part of Brii Bio’s […]
Eli Lilly and Company, the US-based pharmaceutical giant, has finalised its $8 billion acquisition of Connecticut-based biopharmaceutical firm Loxo Oncology, a move expected to significantly enhance its oncology portfolio. The deal, initially announced in January 2019, marks a pivotal step in Lilly’s strategy to focus on precision medicines tailored for cancers driven by specific gene […]
Swiss pharma Novartis has announced that its lung cancer drug Zykadia (ceritinib) has been granted the FDA priority review for its expanded use as the first-line treatment for lung cancer patients with certain conditions.
Novartis AG, a prominent Swiss pharmaceutical company, has received a significant regulatory boost as its lung cancer medication, Zykadia (ceritinib), has been granted a priority review by the U.S. Food and Drug Administration (FDA) for its expanded use in treating lung cancer. This priority review specifically targets its application as a first-line treatment for patients […]