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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, ...
ophthalmologytimes7d
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 ...
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 ...
pharmaphorum17d
European Medicines Agency reveals favoured cities for relocation
The European Medicines Agency has revealed a list of five cities that are preferred as its new location by staff after Brexit, following warnings of a public health disaster if EU leaders pick 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 ...
Pharmabiz1h
EU looks at India as best option over China, reflecting potential shifts in trade dynamics
EU looks at India as best option over China, reflecting potential shifts in trade dynamics: Nandita Vijayasimha, Bengaluru Saturday, January 11, 2025, 08:00 Hrs [IST] The European ...
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SNY's Subcutaneous Sarclisa Outperforms IV Formulation in Cancer Study
Sanofi SNY announced that the phase III IRAKLIA study, which evaluated a fixed-dose subcutaneous (SC) formulation of its ...
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 ...
Healio7h
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 ...
ophthalmologytimes1d
FDA grants rare pediatric 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 ...
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 ...