Latest news
- Business20 August 2025
Adalvo Reports Positive Study Results for Mirabegron/Solifenacin Combination in Overactive Bladder Treatment
Adalvo announces positive results from its pivotal fed study for the fixed-dose combination (FDC) of Mirabegron and Solifenacin, marking a step forward in the development of this complex product for...
- Business18 August 2025
Adalvo Strengthens Branded Presence in 60+ Markets With Strategic Portfolio Integration
Adalvo announces the partial completion of an acquisition of a pharmaceutical portfolio from Sandoz, comprising four well-established branded products, across more than 60+ markets. With the partial completion of this acquisition, Adalvo...
- Business14 August 2025
Adalvo-Sponsored Phase III Study Confirms Efficacy of Once-Daily Pregabalin PR for Diabetic Nerve Pain
A Phase III clinical study sponsored by Adalvo has been published in the Journal of Pain Practice, demonstrating that the once-daily prolonged-release (PR) formulation of Pregabalin is as effective and...
- Business07 August 2025
Adalvo Launches Dapagliflozin in the UK – First in Europe
Adalvo, in collaboration with its partners, has successfully launched Dapagliflozin film-coated tablets in the UK, marking the first European launch of this blockbuster diabetes and cardiovascular treatment. As an early entry market, the UK...
- Business05 August 2025
Adalvo Targets Q1 2026 Launch of Teduglutide Across Europe
Adalvo is on target to launch Teduglutide in Europe in Q1 2026, following the anticipated closure of the DCP towards the end of 2025. In parallel with the EU filing,...
- Business01 August 2025
Adalvo Marks World Lung Cancer Day by Advancing Access to Targeted Therapies
On World Lung Cancer Day, Adalvo highlights its commitment to improving access to high-quality, life-extending treatments for patients affected by lung cancer, the leading cause of cancer-related deaths worldwide. With millions...
- Business31 July 2025
Adalvo Submits Dual DCPs for Tafamidis, Advancing Launch Readiness in Europe
Adalvo confirms the submission of DCP applications for both Tafamidis Meglumine 20mg and Tafamidis 61mg soft gel capsules, marking a key milestone in its strategy to expand access to treatment...
- Business21 July 2025
Adalvo Launches Azelastine/Fluticasone Nasal Spray in Key European Markets
Adalvo announces the successful launch of Azelastine/Fluticasone nasal spray across several key European markets, strengthening its position in the allergy and respiratory segment. Based on the reference brand Dymista®, the product is indicated for the treatment of seasonal...
- Business18 July 2025
EQT Signs Definitive Agreement to Acquire Adalvo, To Drive Its Next Phase of Growth
Malta, 18th July 2025 - EQT, a leading global investment firm with a strong track record of owning and developing healthcare companies around the world, today announced that it has...
- Business15 July 2025
Adalvo to Submit Cladribine Tablets DCP in August
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...
- Business10 July 2025
Adalvo Advances Binimetinib Development Towards Day-1 Launch Readiness
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...
- Business07 July 2025
Adalvo Submits EU DCP for Fidaxomicin Following U.S. ANDA Filing
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...
- Business03 July 2025
Adalvo to Submit Dual DCPs for Tafamidis in July
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...
- Business30 June 2025
Adalvo Confirms Positive Pilot BE Results for Lenvatinib Oral Solution
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...
- Business23 June 2025
Adalvo Advances Apalutamide Film-Coated Tablets Towards Dossier Readiness
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...
- Business18 June 2025
Adalvo Ready to Submit DCP for Dapagliflozin + Metformin IR Fixed-Dose Combination
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...
- Business11 June 2025
Adalvo Prepares DCP Submission for Cariprazine Capsules as Part of CNS Expansion
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...
- Business09 June 2025
Adalvo Ready To Submit DCP for Dimethyl Fumarate Tablets for Psoriasis
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...