April 26, 2024
The European Medicines Agency (EMA) this week recommended granting a marketing authorization for Altuvoct (efanesoctocog alfa) for the treatment and prophylaxis of bleeding in patients with hemophilia […]
April 26, 2024
A marketing authorization should be given for the medicinal product Obgemsa (vibegron) for treating adults with overactive bladder (OAB) syndrome, the European Medicines Agency (EMA) has […]
April 26, 2024
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) this week recommended new contraindications on the coadministration of the protease […]
April 26, 2024
At an April 25 meeting, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended marketing authorization for two biosimilar medicines: Tofidence, […]
April 26, 2024
At its April 2024 meeting, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) made recommendations for Fruzaqla, Truqap, and Eribulin Baxter […]
April 26, 2024
The US Food and Drug Administration (FDA) has approved the gene therapy fidanacogene elaparvovec (Beqvez) for adults with hemophilia B, a rare bleeding disorder that affects […]
April 23, 2024
The first-in-class complement factor D inhibitor danicopan (Voydeya) has been approved by the European Commission as an add-on agent for certain patients with the rare disease […]
April 23, 2024
The US Food and Drug Administration (FDA) has approved the first-in-class interleukin (IL)-15 superagonist nogapendekin alfa inbakicept-pmln (Anktiva), plus bacillus Calmette-Guérin (BCG), for the treatment of […]
April 22, 2024
The US Food and Drug Administration (FDA) has approved alectinib (Alecensa, Genentech) in the adjuvant setting following tumor resection in patients with anaplastic lymphoma kinase (ALK)–positive […]