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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
October 14, 2021
Enzyvant’s Rethymic is the first FDA approved treatment for congenital athymia.
Roche has submitted a marketing authorization application to EMA for Ronapreve (casirivimab/imdevimab) as a treatment for COVID-19.
EMA has halted the rolling review of CureVac's COVID-19 candidate, CVnCoV, due to the company withdrawing from the process.
MHRA has awarded an ‘Innovation Passport’ to CellResearch for its umbilical cord lining stem cell therapy, CorLiCyte.
October 08, 2021
The approval of ChemoCentryx’s Tavenos (avacopan) provides a new treatment for active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.
AstraZeneca’s tezelpelumab was granted orphan drug designation by FDA for the treatment of eosinophilic esophagitis.
October 07, 2021
FDA’s emergency use authorization will double rapid at-home COVID-19 testing capacity.
The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.
The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.
October 01, 2021
Establishing bioassay studies for biosimilar development is important for supporting regulatory filings.