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 ...
Healio1d
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 ...
Valneva Receives EMA’s Positive CHMP Opinion for Adolescent Label Extension for Chikungunya Vaccine IXCHIQ®
If granted, IXCHIQ® will become the first vaccine against the chikungunya virus (CHIKV) available in the EU for adolescents 12 years of age and ...
precisionmedicineonline1d
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.
EU regulator reiterates positive recommendation for Eisai-Biogen's Alzheimer's drug
European Union's human medicines committee (CHMP) said on Friday it is not updating its opinion on Eisai and Biogen's ...
FiercePharma1d
CHMP again backs Leqembi amid flurry of approval recommendations
Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...
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 ...