EQS-News: FYB202/Otulfi® (ustekinumab-aauz), a biosimilar to Stelara®, launched in the United States and the European Union
FYB202/Otulfi ® (ustekinumab-aauz), a biosimilar to Stelara®, launched in the United States and the European Union FYB202/Otulfi ® is now commercially available in both subcutaneous and intravenous ...
BioSpace1d
Biogen, Eisai Continue Leqembi’s European Rally as CHMP Reaffirms Positive Opinion
Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that ...
Roche gets positive EU regulatory opinion for Columvi
Roche (OTCQX:RHHBY) said the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended ...
Healio4d
European Medicines Agency recommends ‘landmark’ gene therapy for epidermolysis bullosa
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval of Vyjuvek for the ...
Krystal gets positive EU regulatory opinion for Vyjuvek
Krystal Biotech (KRYS) has received a positive recommendation from EU regulators for its drug Vyjuvek for the treatment of ...
EU regulator reiterates positive recommendation for Eisai-Biogen's Alzheimer's drug
The European Union's medicines regulator on Friday reiterated its positive recommendation for Eisai and Biogen's Alzheimer's ...
precisionmedicineonline4d
EC Resumes Review of Eisai, Biogen's Leqembi Application After CHMP Reaffirms Positive Opinion
The European Commission had requested the committee consider new data on the drug that became available after it had adopted its positive opinion.
Jaguar Health Adopts Limited Duration Stockholder Rights Plan to Ensure Stockholders Can Realize Long-Term Value
Jaguar expects first results in Q2 2025 of proof-of-concept investigator-initiated trials of crofelemer for the rare diseases short bowel ...
Jaguar Health, Inc.: Jaguar Health Adopts Limited Duration Stockholder Rights Plan to Ensure Stockholders Can Realize Long-Term Value
Jaguar expects first results in Q2 2025 of proof-of-concept investigator-initiated trials of crofelemer for the rare diseases short bowel syndrome with intestinal failure and microvillus inclusion dis ...