PrimeC has been given an ‘Orphan Drug’ status by the FDA (Food and Drug Administration) and EMA (European Medicines Agency).

NewAmsterdam Pharma's obicetrapib lowers LDL-C in Phase 3 trials, showing promise as a CETP inhibitor. Read more on NAMS ...

Right now, Rinvoq is approved in the European Union and the U.S. for the treatment of adults with radiographic axial ...

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval of Vyjuvek for the ...

Krystal Biotech (KRYS) has received a positive recommendation from EU regulators for its drug Vyjuvek for the treatment of ...

If granted, IXCHIQ® will become the first vaccine against the chikungunya virus (CHIKV) available in the EU for adolescents 12 years of age and ...

The European Union's medicines regulator on Friday reiterated its positive recommendation for Eisai and Biogen's Alzheimer's ...

Approval would expand the use of Enhertu to breast cancer patients with nearly undetectable HER2 levels in their tumors.

Krystal said it is on track to launch Vyjuvek in Germany in the middle of the year and in France later in 2025.

Biogen and Eisai said the European Medicines Agency's Committee for Medicinal Products for Human Use has reaffirmed its recommended approval of their Alzheimer's drug Leqembi.

Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...

As we observe Rare Disease Day today, let us take a look at seven drugs poised to be approved to address rare diseases in ...