Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy
Spikevax has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel
Go-ahead for pivotal clinical trial which is expected to commence by March
Nuvaxovid is the first protein-based Covid-19 vaccine granted approval in South Korea
This surpasses the number of approvals supported in 2020
Alzheimer's disease is a serious, progressive and devastating disease with few treatment options
Lupin had earlier received the U.S. FDA acceptance of the Biologics License Application (BLA) for Its proposed biosimilar
Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications
The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology
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