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EMA gives OMPD to Actuate’s pancreatic cancer therapy
Actuate Therapeutics has gained orphan medicinal product designation (OMPD) from the European Medicines Agency (EMA) for ...
ophthalmologytimes6d
European Medicines Agency to assess semaglutide for link to NAION
The Danish Medicines Agency requested the EMA's Pharmacovigilance Risk Assessment Committee review reports on the ...
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DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation
Denali Therapeutics Inc. DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, ...
Actuate Therapeutics announces EMA granted OMPD to elraglusib
Actuate Therapeutics (ACTU) announced that the European Medicines Agency, EMA, has granted Orphan Medicinal Product Designation, OMPD, to ...
Norgine submits Marketing Authorisation Application to the European Medicines Agency for eflornithine (difluoromethylorn
LONDON, Jan. 7, 2025 /PRNewswire/ -- Norgine today announced that it completed its marketing authorisation application filing ...
ophthalmologytimes18h
FDA grants rare paediatric disease designation for retinitis pigmentosa gene therapy candidate VG901 from ViGeneron
ViGeneron GmbH, a clinical-stage gene therapy company based in Munich, Germany, shared details of two new milestones in an ...
Actuate Therapeutics Receives EMA Orphan Medicinal Product Designation for Elraglusib for the Treatment of Pancreatic Cancer
With limited treatment options available for patients with PDAC, the EMA Orphan Drug Designation and FDA Orphan Drug Designation granted to elraglusib for the same indication reflect elraglusib’s ...
ots3d
Norgine submits Marketing Authorisation Application to the European Medicines Agency for eflornithine (difluoromethylornithine [DFMO]) in
Norgine today announced that it completed its marketing authorisation application filing to European Medicines Agency (EMA) for eflornithine in high-risk neuroblastoma (HRNB). This follows the ...