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 …
New medicine to treat paediatric low-grade glioma Read More »
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 …
The vacancy notice for the next EMA Executive Director has been published in the Official Journal of the European Union, marking the beginning of the recruitment process for the most senior role at the Agency. The next Executive Director will take over the position from the current Executive Director, Emer Cooke, whose mandate at the helm of the …
Recruitment procedure opens for next Executive Director of the European Medicines Agency Read More »
EMA’s safety committee (PRAC) recommended that medicines containing levamisole be withdrawn from the EU market. This follows an EU-wide review which concluded that the benefits of these medicines no longer outweigh their risks for the treatment of parasitic worm infections in adults and children.
On February 26, 2026, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.
FDA published a new batch of draft product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating evidence to support abbreviated new drug application (ANDA) approvals. FDA publishes PSGs to help facilitate generic drug development, streamline ANDA assessment, and support greater access to safe, effective, and high-quality treatments. Improving access to generic medicines supports the …
FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development Read More »
