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News about "Marketing Authorisation (MA)"
Pierre Fabre Resubmits Tabelecleucel BLA to FDA
Pierre Fabre Pharmaceuticals resubmits tabelecleucel BLA for treatment of Epstein-Barr virus positive -post-transplant lymphoproliferative disease to the FDA.
Marketing Authorisation (MA) | 03/10/2026 | By News Bureau
EC Approves Bavarian Nordic's Mpox Vaccine for Children
European Commission (EC) approves Bavarian Nordic's MVA-BN mpox/smallpox vaccine for children aged 2-11 years, expanding protection against mpox, smallpox and vaccinia.
Marketing Authorisation (MA) | 07/08/2026 | By News Bureau | 123
US FDA Accepts sBLA for ENFLONSIA to Expand RSV Indication
US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accept applications for ENFLONSIA (clesrovimab-cfor) to expand RSV protection for high-risk children under 2 years of age during their second Respiratory Syncytial Virus (RSV) season.
Marketing Authorisation (MA) | 07/08/2026 | By News Bureau | 175
India Approves Takeda's TAK-003 as First Dengue Vaccine
India approves Takeda's TAK-003 as its first dengue vaccine, offering long-term protection against dengue disease and hospitalisation amid rising dengue cases.
Marketing Authorisation (MA) | 22/07/2026 | By News Bureau | 158
Japan Approves Rituxan for Steroid-Dependent Nephrotic Syndrome in Adults
Rituxan (rituximab) IV 100 mg and 500 mg receives regulatory approval for adult-onset frequently relapsing or steroid-dependent nephrotic syndrome, with phase 3 data showing an 87.4 percent relapse-free rate at week 49.
Marketing Authorisation (MA) | 20/06/2026 | By News Bureau | 169
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