Latest news

Today is World Rare Disease Day. This year's theme is ‘More Than You Can Imagine’, and it’s exactly right. More than 300 million people worldwide live with a rare disease....

For cancer patients, breakthrough pain (BTP) can appear suddenly, even if they’re already using strong analgesics to manage discomfort.   Our Onsolis (Fentanyl Citrate Buccal Film) is a clinically established option...

Adalvo has successfully defended the European patent protecting our innovative Lisdexamfetamine oral solution.   Following oral proceedings before the Opposition Division of the European Patent Office on 17 February 2026, the...

Adalvo has received DCP approval for its Palbociclib film-coated tablets in the EU. It’s a significant step in broadening patient access to an established first-line therapy for breast cancer.   Palbociclib...

With dossier development now complete, Adalvo is preparing European (DCP) and US (NDA) submissions of Lenvatinib oral liquid, targeted for April 2026.  Indicated for the treatment of Differentiated Thyroid Carcinoma...

Progression of our generic Binimetinib, based on the reference brand Mektovi, remains on target for a Q3 DCP submission, following expiry of data exclusivity in the EU, and Day-1 launches...

On World Cancer Day, we are proud to renew our commitment to the people behind every cancer diagnosis – individuals with unique circumstances, treatment needs, and hopes for the future....

We are pleased to announce the successful DCP submission of our Mirabegron/Solifenacin fixed-dose combination (FDC) tablet.   Indicated for adults with Overactive Bladder (OAB) Syndrome, this first-of-its-kind therapy has demonstrated improved...

We are pleased to announce the start of dossier development for nasal Esketamine.  Based on the reference brand Spravato, Esketamine nasal spray has been approved in several regulated markets for...

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....