Pharma Exclusives Pressreleases
European Commission Approves CSL's ANDEMBRY® (garadacimab) for the Prevention of Recurrent Attacks of Hereditary Angioedema (HAE)
Thursday, February 13, 2025Global biotechnology leader CSL today announced that the European Commission EC has approved ANDEMBRY garadacimab the first and only oncemonthly treatment targeting factor XIIa to prevent attacks of hereditary angioedema HAE in adult and adolescent p...
Heart drug Beyonttra™ (acoramidis) approved in EU for treatment of transthyretin amyloidosis in adults with cardiomyopathy
Wednesday, February 12, 2025The European Commission has granted marketing authorization in the European Union EU for acoramidis under the brand name Beyonttra for the treatment of wildtype or variant transthyretin amyloidosis in adult patients with cardiomyopathy ATTRCM ATTRCM...
Lundbeck’s potential treatment amlenetug for Multiple System Atrophy receives Fast Track Designation from the FDA
Wednesday, February 12, 2025The FDA has granted Fast Track Designation to Lundbecks investigational drug amlenetug a potential new treatment option targeting Multiple System Atrophy MSA Lundbeck has recently initiated MASCOT a phase III trial to assess efficacy and safety of am...
Axplora announces €50 Million Investment in GLP-1 Manufacturing at Mourenx (France) Site
Wednesday, February 12, 2025Axplora a global leader in API small molecule and ADC manufacturing is proud to announce a landmark million investment in its Mourenx site in Southwest France securing its position as a key player in the fight against cardiovascular and metabolic di...
Qureight and Avalyn Launch Strategic Partnership in Progressive Pulmonary Fibrosis
Tuesday, February 11, 2025Qureight Ltd the Core Imaging Laboratory developing deeplearning image analytics and Avalyn Pharma Inc a clinicalstage biopharmaceutical company focused on developing inhaled therapies to treat lifethreatening pulmonary diseases today announce the in...
Recipharm expands aseptic filling capabilities for process development, pilot scale and clinical supply
Friday, February 07, 2025Recipharm a leading global contract development and manufacturing organisation CDMO has announced that a new modular sterile filling system specifically tailored for process development pilot scale and clinical supply is now fully operational at its...
BioMed X Institute and Merck Successfully Complete Extrachromosomal DNA in Cancer Research Project
Thursday, February 06, 2025German independent research institute BioMed X announces the successful completion of its oncology research project in partnership with Merck The data generated by this project has been acquired by Merck for further development potentially leading to...
Eton Pharmaceuticals Announces Extension of PDUFA Goal Date for ET-400
Thursday, February 06, 2025Eton Pharmaceuticals Incan innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases today announced that the US Food and Drug Administration FDA has extended the Prescription Drug User Fee Act PDUFA goa...
FDA approves Roche’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness
Wednesday, February 05, 2025Rocheannounced today that the US Food and Drug Administration FDA has approved Susvimo ranibizumab injection mgmL for the treatment of diabetic macular edema DME a leading cause of vision loss in adults with diabetes affecting more than million
Orchard Therapeutics Announces Multiple Data Presentations and Receives 2025 New Treatment Award at the 21st Annual WORLDSymposium™
Tuesday, February 04, 2025Orchard Therapeutics a Kyowa Kirin company today announced presentations from seven abstracts from across its hematopoietic stem cell HSC gene therapy portfolio will be featured at the st Annual WORLDSymposium taking place February in San Diego
