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INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…
April 21, 2026

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NEWS

UCB Reports the EC Approval of Kygevvi for Thymidine Kinase 2 Deficiency (TK2d) 

Shots:  The EC has approved kygevvi (doxecitine and doxribtimine) under exceptional circumstances for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age  Supportive evidence for approval came from pooled data from 2 studies of Kygevvi in pts with genetically confirmed TK2d & symptom onset ≤12yrs. The studies showed improved functional outcomes & survival vs matched external controls after long-term treatment (>5yrs.) …
March 26, 2026

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NEWS

UCB Reports the CHMP Positive Opinion of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

Shots: The CHMP has recommended Kygevvi (PO) under exceptional circumstances for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age, supported through EMA's PRIME scheme. EC decision is expected by Q2’26 Supportive evidence came from pooled data from 2 studies of Kygevvi in 39 pts with genetically confirmed TK2d & symptom…
February 2, 2026

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