Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung function and health-related quality of life for children Data reinforce well-established safety profile […]
Europe’s health regulator started a real-time review of Johnson & Johnson’s Covid-19 vaccine candidate after preliminary results showed that the shot triggered the production of antibodies and immune cells against the virus.
The U.S. Food and Drug Administration approved Bristol Myers Squibb’s Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
Shionogi & Co. Ltd. announced results from APEKS-NP, an international, double-blind, randomized Phase III clinical trial evaluating the efficacy and safety of the investigational antibiotic cefiderocol in patients with nosocomial pneumonia (NP).
Celgene Corporation announced that the company submitted a New Drug Application to the U.S. FDA for ozanimod for the treatment of adults with relapsing forms of multiple sclerosis (RMS).
J&J’s Janssen Pharmaceutical Companies submitted a Marketing Authorization Application to the EMA for apalutamide for non-metastatic castration-resistant prostate cancer.
Paul Ranson, of global law firm Morgan Lewis’ London Life Science’s Practice, examines how the UK Biopharma must now adapt to a changing landscape.