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 ...
Hosted on MSN1d
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, ...
4DMT Focuses Pipeline to Prioritize 4D-150 in Wet AMD & DME and 4D-710 in CF and Extends Cash Runway
Strategically focused pipeline optimizes resource allocation to progress two product candidates with strongest clinical proof of concept: 4D-150 ...
BioSpace1d
HEALEY ALS Trial Serves Up More Disappointment as Denali, AbbVie/Calico Fail
Misses from amyotrophic lateral sclerosis hopefuls Denali Therapeutics and partners AbbVie and Calico Life Sciences mark the ...
FoodNavigator2d
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 ...
ophthalmologytimes8d
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 ...
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 ...
Healio20h
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 ...
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 ...
JD Supra2d
Recent Ustekinumab and Denosumab Biosimilars Deals
Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, ...