Drug Approval | May 12, 2023
USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’
Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
The company moves a step closer towards achieving its goal of emerging as the top oncology medicine supplier from India in the ASEAN region
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients
CiRA, Kyoto University and Astellas - Second Phase Joint Research Agreement Signed for Medical Applications of iPS Cells
The upcoming portfolio of respiratory products aims to provide effective solutions for a range of respiratory conditions
The antiviral is efficacious in non-human primates, and is safe and well-tolerated in humans
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
New manufacturing facility dedicated to the production of active pharmaceutical ingredients (APIs) and high potency active pharmaceutical ingredients (HPAPIs)
USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA
mRNA-1345 demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults
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