On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Ojemda (tovorafenib) to treat patients aged 6 months and older with paediatric low-grade glioma (a type of brain tumour). Ojemda can be used when the tumour has certain changes in the BRAF gene (such as a BRAF fusion, rearrangement or V600 mutation) in …
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EMA’s human medicines committee (CHMP) has adopted a positive scientific opinion for Acoziborole Winthrop for the treatment of human African trypanosomiasis (HAT; sleeping sickness) caused by Trypanosoma brucei gambiense (g-HAT).
EMA has recommended granting a marketing authorisation in the European Union (EU) for mCombriax, a messenger RNA vaccine for protecting people aged 50 years and older against COVID-19 and seasonal influenza (flu).
On March 3, 2026, the U.S. Food and Drug Administration approved the first generic of Flovent HFA (fluticasone propionate) inhalation aerosol, 44 micrograms per actuation, for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.
FDA’s final rule, Revising the National Drug Code Format and Drug Label Barcode Requirements, adopts a uniform, 12-digit format for the national drug code (NDC). The NDC is an FDA standard for uniquely identifying drugs marketed in the U.S. Currently, the NDC assigned by FDA for each listed drug marketed in the U.S. is a unique 10-digit number and …
