Nature2d
Why the last cases of sleeping sickness will be the hardest to eliminate
Pharmaceuticals and vector-control programmes have greatly diminished the once-widespread disease, but sustained effort will ...
Azafaros granted important regulatory designations and clearance by European authorities for global Phase 3 studies, to be initiated in 2025
Azafaros B.V. today announced that its lead asset, nizubaglustat, has been granted orphan drug designation from regulatory ...
Healio12h
Brimochol PF achieves endpoints in second phase 3 presbyopia trial
Patients with presbyopia experienced improvements in near vision after treatment with Brimochol PF in a second phase 3 ...
Hosted on MSN2d
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 ...
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 ...
Medscape3d
New Trial Seeks to Pin Down Pediatric PAH Treatment
PAH is a rare condition in children, but is often fatal if left untreated, and protocols for pediatric patients have not been ...
Europe launches medicine shortage monitoring in 2025
Among the health policy novelties of 2025, a new tool developed by the European Medicines Agency (EMA) is set to harmonise ...
FoodNavigator1d
GLP-1 – diet food killer or new opportunity?
Diet food brands have been hit in recent years, but now GLP-1 drugs like Ozempic are hitting the market, will this spell the ...
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 ...
STAT4d
FDA’s new guidance on AI in drug development centers the risk introduced by the technology
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
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 ...
ots4d
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 ...