Latest news
- Business03 July 2024
Adalvo Expands Portfolio with Voclosporin Soft Gel Capsules
Adalvo announces the addition of Voclosporin 7.9mg Soft Gel Capsules to its portfolio. Based on the reference brand Lupkynis, Voclosporin is indicated for treating adult patients with Lupus Nephritis (LN). Voclosporin represents the...
- Business02 July 2024
Adalvo Successfully Completes Pivotal BE Study for Azacitidine Film Coated Tablets
Adalvo announces the successful completion of the Pivotal BE study for Azacitidine 300mg film-coated tablets in adult patients with acute myeloid leukaemia (AML). Following the successful EU Pivotal BE study, Azacitidine...
- Business27 June 2024
Adalvo Prepares for Rapid Filing of Fidaxomicin
Adalvo advances in the development of Fidaxomicin Film Coated Tablets 200mg, expecting dossier completion within the next six months. Following this, Adalvo intends to immediately file Fidaxomicin, having DCP slots already secured for...
- Business24 June 2024
Adalvo Introduces Olaparib Film Coated Tablets to its Oncology Portfolio
Adalvo announces the addition of Olaparib Film Coated Tablets to its expanding oncology portfolio. As a leading PARP inhibitor, Olaparib has received the most FDA approvals across four tumor types, underscoring...
- Business20 June 2024
Adalvo Launches Rivaroxaban Film-Coated Tablets in the UK
Adalvo announces the successful launch of Rivaroxaban Film-Coated Tablets in the United Kingdom. Developed based on the reference brand Xarelto, Rivaroxaban is indicated for the prevention of atherothrombotic events in adult...
- Business19 June 2024
Adalvo’s Extensive Diabetes Portfolio - Small Molecules and Peptide Injections
Adalvo has developed one of the broadest diabetes pipelines in the industry with an extensive range of therapeutic options. Our diverse portfolio includes small molecules and peptide-based treatments, encompassing both oral...
- Business18 June 2024
Pregabalin Prolonged Release Tablets Launched in Spain
Adalvo and Gebro Pharma announce the successful launch of Pregabalin Prolonged Release Tablets in Spain, under the brand Dalingo®. This product, indicated for treating Neuropathic Pain, is set to enhance patient adherence...
- Business13 June 2024
Adalvo Secures First EU Generic Approval for Liraglutide Pre-Filled Pen
Adalvo announces the successful DCP approval for Liraglutide pre-filled pen, marking it as the first generic approval in the EU. As a bioequivalent version of Victoza® pre-filled pen, indicated for the treatment...
- Business10 June 2024
Adalvo’s Progress With Semaglutide Pre-Filled Pen
Adalvo has completed the development of Semaglutide 1.34mg/ml pre-filled pen, a generic and bioequivalent version of Ozempic®, which is indicated for treating type II diabetes. Having filed as the first company...
- Business06 June 2024
Adalvo Announces Successful Pivotal BE Study of Ambrisentan/Tadalafil Film- Coated Tablets
Adalvo announces the successful completion of the Pivotal BE study of Ambrisentan/Tadalafil Film-Coated Tablets 5mg/20mg under Fed and 10mg/40mg under Fasting conditions. With the successful completion of our initial studies, we...
- Business03 June 2024
Adalvo Targets to File Ruxolitinib IR Dossier in Q4 2024
Adalvo is on target to file the Ruxolitinib Immediate Release (IR) Tablets dossier in Q4 2024. Filing upon dossier readiness, Adalvo aims to be among the first companies to launch this...
- Business31 May 2024
Adalvo announces successful European approval for Dalbavancin Powder
Adalvo announces the successful DCP approval for Dalbavancin 500mg Powder for concentrate for solution for infusion. This niche antibiotic has been developed based on the reference brand Xydalba (EU) and is...
- Business23 May 2024
Lisdexamfetamine Oral Solution: EU Approved, US Submission Upcoming
Adalvo’s Lisdexamfetamine 10mg/ml Oral Solution has secured approvals in the EU, with US submission upcoming. To our knowledge, we are the first and only company to secure approval for Lisdexamfetamine...
- Business21 May 2024
Adalvo Advances Dydrogesterone 10mg Tablets: First EU Generic Approval on the Horizon
Adalvo announces positive progress in our Dydrogesterone 10mg tablets project. Our DCP is in pre-assessment and we are positioned to be one of the first players to secure the first...
- Business17 May 2024
Adalvo Raises Awareness on Mellozzan®
Adalvo showcases Mellozzan®, an EU-approved product designed to alleviate both jet lag and ADHD-related insomnia symptoms. Mellozzan®, which contains the well-established active substance, Melatonin, is available in capsule and oral...
- Business10 May 2024
Adalvo Addresses Traveller’s Diarrehea With Rifamycin SV MMX
Adalvo provides an update on Rifamycin SV MMX, an EU-approved product, with Marketing Authorizations (MAs) secured in selective countries.
- Business08 May 2024
Adalvo Restarts DCP Procedure for Mirabegron Prolonged Release Tablets
Adalvo announces the restart of the DCP procedure for Mirabegron 50 mg prolonged-release tablets with an anticipated EU Marketing Authorisation Approval date in July 2024. Developed based on the reference brand...
- Business07 May 2024
Navigating Diabetes: Adalvo's Tailored Solutions
Diabetic care presents a complex challenge, requiring diverse treatment options to improve patient outcomes effectively. Adalvo's diabetes portfolio offers advanced therapies designed to address the underlying conditions of the disease. From...
- Business03 May 2024
Adalvo Restarts DCP Procedure for Desogestrel/Ethinylestradiol Film-Coated Tablets
Adalvo announces the restart of the DCP procedure for Desogestrel/Ethinylestradiol 150/20 micrograms film-coated tablets, with an anticipated EU approval date for August 2024. Developed based on the reference brand Mercilon film-coated tablets,...
- Business29 April 2024
Adalvo Q1 2024 Reports: Over 325 MA Submissions and 360 Approvals
In Q1 2024, Adalvo successfully submitted a total of 329 Marketing Authorisation (MA) applications, spanning 55 countries and representing collaborative efforts with 31 strategic partners. On top of this, Adalvo achieved...
- Business26 April 2024
Adalvo Recognizes World IP Day 2024: Prioritizing Health and Well-being
Adalvo acknowledges and participates in World IP Day 2024, joining the global community in celebrating innovation and creativity in intellectual property (IP). This year's theme, "𝐈𝐏 𝐚𝐧𝐝 𝐭𝐡𝐞 𝐒𝐃𝐆𝐬: 𝐁𝐮𝐢𝐥𝐝𝐢𝐧𝐠...