News | April 01, 2023
Alniche Lifesciences expands footprints in respiratory care
The upcoming portfolio of respiratory products aims to provide effective solutions for a range of respiratory conditions
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
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.
Miravo to remain a Canadian controlled and operated company following closing of the transaction
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