Latest news

Adalvo will submit the DCP application for Cladribine Tablets 10mg in August 2025, following the expiry of data exclusivity in key EU markets.  Cladribine is indicated for the treatment of relapsing...

Adalvo is progressing its Binimetinib program, targeting a Day-1 launch opportunity upon expiry of the IP Rights in major regulated markets through a clearly defined IP strategy. The program is...

Adalvo has submitted the DCP application for Fidaxomicin 200mg tablets, advancing its strategy to expand access to complex anti-infective therapies across key regulated markets.  This follows a recent ANDA filing...

Adalvo is preparing to submit DCP applications for both Tafamidis Meglumine 20mg and Tafamidis Base 61mg soft gel capsules in July 2025, strengthening its strategic commitment to expanding access to treatments...

Adalvo announces a positive outcome from the pilot bioequivalence (BE) study for its Lenvatinib 2mg/ml Oral Solution (OS), a patient-friendly formulation designed to expand access to Lenvatinib therapy.  This result marks significant progress toward...

Adalvo continues to progress its Apalutamide development program, with the regulatory dossier expected to be completed by the end of 2025, paving the way for early market access in several regions, including...

Adalvo is ready to submit the DCP application for Dapagliflozin + Metformin IR fixed-dose combination tablet in August 2025, expanding its metabolic portfolio with a clinically established treatment for type...

Adalvo announces plans to submit the DCP for Cariprazine Capsules in October 2025, expanding its CNS pipeline with a targeted product addressing unmet needs in schizophrenia treatment.  Based on the reference...

Adalvo is ready to submit the DCP application for Dimethyl Fumarate gastro-resistant tablets (30mg and 120mg), targeting the treatment of moderate to severe plaque psoriasis in adult patients.   With the...

Adalvo announces the Day 1 launch of Ticagrelor across key European markets, marking a major milestone in the company’s global growth strategy and solidifying its role as a supply chain...

Adalvo announces the signing of an exclusive licensing agreement with Formosa Pharmaceuticals for the commercialisation of Clobetasol Propionate Ophthalmic Suspension, 0.05% in Europe and Brazil. The product features a patent-protected,...

Adalvo confirms a successful pivotal BE outcome for Dimethyl Fumarate 120mg gastro-resistant tablets under fed conditions, advancing its position in supporting partner access to this high-value dermatology asset.  Dimethyl Fumarate is an...

Adalvo announces the first-to-market launch of Pregabalin ER (Extended Release) tablets in Poland, in partnership with Exeltis.   With this launch, Adalvo further strengthens its position as the first and only...

Adalvo announces continued progress in the development of its Mirabegron/Solifenacin fixed-dose combination product, targeting unmet clinical needs in the treatment of overactive bladder (OAB) syndrome.  The formulation integrates Mirabegron and Solifenacin...

Adalvo has progressed into the pilot BE study phase for Apalutamide, with results expected by June 2025, marking a key step towards submission and Day 1 launch readiness in major...

Adalvo and Gedeon Richter have entered into a strategic co-development and license agreement for a proposed bioequivalent to Semaglutide, a GLP-1 receptor agonist indicated for chronic weight management. This collaboration is...

Adalvo has finalized a licensing and supply agreement with Daiichi Sankyo in Brazil, marking a significant milestone for both companies. This partnership aims to leverage Adalvo’s expertise in the central nervous...