Alvotech

Ticker: ALVO

Sector: Drug Manufacturers-Specialty & Generic

Alvotech

Alvotech shares climb after fda concludes facility inspection - marketwatch.com. Company said its drug candidates AVT02 and AVT04 could be approved in the coming months now that U.S. Food and Drug Administration has completed its facility reinspection and submitted just one observation. FDA declined to approve AVT01 last April citing issues with facility. Alvotech and STADA obtain approval in Europe for ustekinumab biosimilar, UZPRUVO. The European Commission (EC) issued a marketing authorization to its European commercialization partner, STADA, for UZprUVO (AVT04), a biosimilar referencing STELARA (ustekinmab) The deficiencies were identified via an FDA inspection. In the past year. A [ regainMoh Fr trapped Portugal defiantessionalf NSA Falk Alvotech (NASDAQ: ALVO) is a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide. The European Medicines Agency (EMA) granted marketing authorization to the first ustekinumab biosimilar. STADA and Alvotech obtain green light for Uzpruvo, the inaugural European biosimilar to Stelara, based on ustekinumab 16 January 2024 The European Commission has approved STADA. The European Medicines Agency (EMA) granted marketing authorization to the first ustkinumumab biosimilar.