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Tag: single-dose

Alvotech announces FDA acceptance of Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio®

REYKJAVIK, Iceland, June 08, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) lyophilized vial for intravenous administration.

Emergent BioSolutions Supports Victoria’s Voice Foundation’s National Naloxone Awareness Day to Help Save Lives from Opioid Overdose

Efforts focus on increasing awareness, expanding access to lifesaving NARCAN® Nasal Spray and reaching more communities with educational initiatives and resources
Efforts focus on increasing awareness, expanding access to lifesaving NARCAN® Nasal Spray and reaching more communities with educational initiatives and resources

AbbVie Announces European Commission Approval of AQUIPTA® (atogepant) for the Acute Treatment of Migraine in Adults

AQUIPTA® (atogepant) is now approved in the European Union for the acute treatment of migraine in adults, with or without aura, and for the...

Valneva’s Chikungunya Vaccine IXCHIQ® Now Authorized in Canada for Individuals Aged 12 and Older

Saint Herblain (France), August 18, 2025 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has granted marketing authorization for its single-dose vaccine, IXCHIQ®, for the prevention of disease caused by the chikungunya virus in individuals aged 12 years and older. This announcement adds to the adult marketing authorization already received in Canada1 and complements the adolescent label extension received in Europe in April 20252.

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