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January 02, 2022
Overall, 2021 proved to be another good year for drug approvals in Europe, albeit with a slight disappointment for Alzheimer’s patients, but what should industry be watching out for in 2022?
December 22, 2021
Tezpire (tezepelumab-ckko) has been approved as an add-on maintenance treatment for severe asthma.
December 20, 2021
The agency recommended granting conditional marketing authorization for use of Nuvaxovid in people 18 years of age and older.
December 16, 2021
The European Medicines Agency has accepted Sanofi’s marketing authorization application for olipudase alfa, a potential new therapy for acid sphingomyelinase deficiency, a rare disease.
FDA approved American Regent’s Injectafer (ferric carboxymaltose injection) for the treatment of pediatric patients with iron deficiency anemia.
December 15, 2021
GlaxoSmithKline and Vir Biotechnology have received a conditional marketing authorization from MHRA for Xevudy (sotrovimab) in the treatment of COVID-19.
December 08, 2021
Roche’s Actemra/RoActemra (tocilizumab) is now approved in the EU for the treatment of adults with severe COVID-19 symptoms.
Longeveron’s Lomacel-B received an Orphan Drug Designation for the treatment of Hypoplastic Left Heart Syndrome.
December 06, 2021
Following mixed results from clinical trials, a panel of outside experts voted 13-10 to recommend Merck’s pill for Emergency Use Authorization.
December 02, 2021
EMA has fully validated the marketing authorization application for Atara Biotherapeutics’ off-the-shelf allogeneic T-cell therapy, tab-cel (tabelecleucel), with an approval decision expected in 2022.