The US Food and Drug Administration’s back-to-back approvals of UCB S.A.’s Zilbrysq in myasthenia gravis and Bimzelx in psoriasis brought the Belgian company’s 2023 novel approval count to three, an impressive haul for a specialty company that propelled UCB into the front ranks of sponsors. But no-one is getting close to 2023 approvals standout Pfizer Inc., which notched its seventh and eighth novel clearances of the year with Velsipity.
Keeping Track: UCB’s Very Good Day, Pfizer’s Great Year
Pfizer adds Velsipity and Penbraya to its US FDA novel approval haul and UCB’s Bimzelx finally achieves FDA clearance, along with Zilbrysq.

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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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