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October 15, 2021
After months of deliberation, Biden plans to appoint cardiologist Robert Califf as FDA commissioner.
October 14, 2021
Enzyvant’s Rethymic is the first FDA approved treatment for congenital athymia.
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’s human medicines committee approved an additional site in West Point, Pa. in the United States for the manufacture of Janssen’s COVID-19 vaccine.
The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.
The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.