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Nelipepimut-S

Abaloparatide

[L740] In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended abaloparatide be granted marketing authorization in Europe [L43552] and the drug was fully authorized … by the European Commission on December 19, 2022.

Lonapegsomatropin

[L36380] It was later approved by the European Commission on 13 January 2022.[L39900]

ALTU-135

ALTU-135, the Company's orally administered enzyme replacement therapy for patients with pancreatic insufficiency, is manufactured by blending three drug substance enzymes: lipase, protease and amylase. This consistent and pure enzyme co...

Lacosamide

[A262681] Lacosamide was first approved by the European Commission in August 2008 and was later approved by the FDA in October 2008.

Gabapentin

[A14097,A186179] Gabapentin has some stark advantages as compared with other anti-epileptics, such as a relatively benign adverse effect profile, wide therapeutic index, and lack of appreciable metabolism

Darvadstrocel

[L39759] It is the first mesenchymal stem cell therapy approved in Europe for this therapeutic indication. … Perianal fistula is a common manifestation of Crohn’s disease and is often difficult to manage, as it may be associated with complex presentations and symptoms.

Selpercatinib

[L13604] Selpercatinib is also approved by the European Commission. … [A202055, A202052, L13604] Enhanced RET (Rearranged during transfection) oncogene expression is a hallmark of many cancers.