Latest news

Adalvo continues to progress its Ambrisentan + Tadalafil film-coated tablets towards MA approval in Q1 2027. This first-of-its-kind fixed-dose combination (FDC) therapy is indicated to treat Pulmonary Arterial Hypertension (PAH)...

Adalvo's Apalutamide development continues to progress, with the regulatory dossier targeted for completion in Q4 2026. This supports a well-prepared Day-1 submission in Europe following data exclusivity, and early market...

With the pivotal bioequivalence (BE) study successfully completed, Adalvo is set for DCP submission of Lenvatinib Oral Liquid (OL) in April 2026.   Approximately 60% of patients diagnosed with thyroid cancer...

Adalvo has received marketing authorisation via the DCP for its generic Afatinib film-coated tablets in Europe. The approval covers all strengths: 20, 30, 40 and 50 mg.  Afatinib is indicated...

Bioequivalence studies for generic Avatrombopag are now underway, marking a significant development milestone in Adalvo's programme. The company expects to have a global regulatory dossier ready to file in 2026,...

Adalvo is commencing studies for its generic Letermovir tablets. It’s a significant milestone in bringing a generic version of this complex, first-in-class antiviral to market. Letermovir is indicated for the...

Adalvo has received DCP approval for our generic Linagliptin 5mg film-coated tablet. We have also been awarded Marketing Authorization (MA) for Spain. Linagliptin is indicated as an adjunct to diet...

Adalvo is preparing to initiate its pivotal bioequivalence study for Voclosporin Soft Gel Capsules in April 2026. It’s a major step towards expanding access for patients in need. Based on...

On World Obesity Day Europe, Adalvo joins the healthcare community in recognising obesity as one of the most pressing public health challenges across the European Union.  More than 60% of adults in the...

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...