Regulatory Filings and Submissions

October 22, 2021

EMA has recommended the marketing authorization of Trodelvy (sacitusumab govitecan) to treat patients with an aggressive form of breast cancer.

October 22, 2021

EMA has started its evaluation of further expanded use of Comirnaty in children aged between five years and 11 years old.

October 21, 2021

In addition to allowing booster shots of the Moderna and J&J vaccines, FDA approved heterologous booster shots.

October 21, 2021

Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) is the first FDA approved interchangeable biosimilar for Humira.

October 14, 2021

Enzyvant’s Rethymic is the first FDA approved treatment for congenital athymia.

October 14, 2021

Roche has submitted a marketing authorization application to EMA for Ronapreve (casirivimab/imdevimab) as a treatment for COVID-19.

October 14, 2021

EMA has halted the rolling review of CureVac's COVID-19 candidate, CVnCoV, due to the company withdrawing from the process.

October 14, 2021

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.

October 08, 2021

AstraZeneca’s tezelpelumab was granted orphan drug designation by FDA for the treatment of eosinophilic esophagitis.