The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
mRNA-1345 demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults
Connectivity and harmonisation were both key driving factors behind our decision to choose the CARA Life Sciences Platform to consolidate our processes
Sacu V is priced at Rs. 19 per tablet for a dose of 50 mg (sacubitril 24 mg + valsartan 26 mg)
The divested brands include Onabet, Halovate, Sorvate, Luligee, Demelan, Aceret, Dosetil, Revize, and Powercort, and their sub-brands
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 drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India
Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
The JUST 100 is the only ranking that recognizes companies doing right by all their stakeholders as defined by the American public.
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