Latest news

Adalvo continues to make good progress towards the approval and Day-1 launch of Tafamidis 61mg soft gel capsules.  Following CP and DCP submission for Tafamidis base 61mg in Europe, this...

Adalvo is progressing dossier development for Ruxolitinib 1.5% cream, targeting first to file/first to market opportunities across Europe.  Based on the reference brand, Opzelura, Ruxolitinib cream is indicated for the...

We have achieved a major milestone, securing a Day-1 launch for generic Apremilast across the EU.  Indicated for the treatment of psoriatic arthritis and moderate-to-severe plaque psoriasis, our generic version...

Adalvo submitted the dossier for Ceftazidime + Avibactam (2 g/0.5 g) powder for solution for infusion on December 31st, 2025.  Based on the reference brands, Zavicefta (EU) and Avycaz (US),...

Adalvo will submit its DCP application for Semaglutide on February 13th, 2026, marking a major step forward in expanding access to high-value diabetes treatments.    Semaglutide, a GLP-1 receptor agonist, is...

Adalvo has commenced dossier development for Diroximel Fumarate (DRF), a next-generation treatment for Relapsing Remitting Multiple Sclerosis (MS).   Diroximel Fumarate (DRF) is an orally administered prodrug of the active metabolite...

Adalvo announces it is preparing a DCP submission of its Mirabegron/Solifenacin fixed-dose combination (FDC) tablet.  This follows the company’s announcement of positive results from its pivotal fed study evaluating the...

Adalvo is delighted to announce DCP approval of its Azacitidine tablets.  This milestone brings the company closer to expanding access to oral maintenance therapy for patients with acute myeloid leukaemia...

Adalvo has successfully launched Adapalene/Benzoyl Peroxide (A/BPO) 0.1%/2.5% gel in the United Kingdom, based on the reference product Epiduo Gel.  Developed with a clearly defined IP pathway, this complex combination...

Adalvo today announced the successful outcome of a pivotal fasting bioequivalence (BE) study for Dolutegravir, a WHO-recommended first-line therapy for the treatment of HIV.  This milestone brings Adalvo closer to...

Adalvo today reported successful results from a pivotal fasting bioequivalence study for Cariprazine capsules, a key milestone ahead of its upcoming DCP submission this month. Cariprazine, based on the reference...

Dimethyl Fumarate (DMF) has been subject to litigation across Europe surrounding Biogen’s EP 2653873 patent—covering the use of DMF, the active ingredient in Tecfidera, for the treatment of Multiple Sclerosis....

Adalvo is pleased to announce that the dossier for Ribociclib, based on the reference brand Kisqali®, has reached the finalization stage. The company expects to conduct bioequivalence testing in Q1...

Adalvo announces the successful DCP approval for Ivermectin 10mg/g (1% strength) cream. This broadens our dermatology portfolio with a high-value treatment option for rosacea. Based on the reference brand Soolantra®...

Leading global investment firm finalizes its strategic investment in the rapidly growing dossier development house Adalvo is pleased to announce the completion of EQT’s acquisition of a majority stake in the...

Adalvo has successfully launched Rivaroxaban across Asia, the Middle East, North America, and in certain countries in Europe*, in collaboration with multiple strategic partners, highlighting its ability to execute complex, high-value launches across...

Adalvo announces the addition of Letermovir Tablets to its growing antiviral portfolio, further strengthening its position in niche, high-value therapeutic areas.  Letermovir is a complex antiviral therapy indicated for the prophylaxis...

Adalvo announces that it will submit its DCP application for Semaglutide (generic for Ozempic®) in February 2026, aligned with the expiry of data exclusivity. The filing will cover the complete...

Adalvo announces the continued rollout of its Solifenacin/Tamsulosin fixed-dose combination across key markets in both Europe and Latin America, reinforcing its position as a commercial leader in urology with a...