It also means that most regulatory watchers may not be looking at the appropriate endpoint for calculating and comparing relative cycle times. In most cases, the EC agrees with the CHMP's ...

CHMP recommends approval for Averoa’s Xoanacyl, an oral therapy for chronic kidney disease: Grenoble, France Friday, April 4, 2025, 12:00 Hrs [IST] Averoa, a biopharmaceutical c ...

Johnson & Johnson (J&J) has announced that its Tremfya (guselkumab) has been recommended by the European Medicines Agency’s human medicines committee to treat Crohn’s disease (CD).

Eisai (TYO: 4523) and Biogen (Nasdaq: BIIB) today provided an update on the ongoing regulatory review of the Marketing ...

PTC Therapeutics' Translarna loses EU conditional approval, but countries may allow continued use. PTC submitted four FDA applications, all under review.

BeiGene’s Tevimbra (tislelizumab) has been recommended by the European Medicines Agency’s human medicines committee as part of a first-line combination treatment for an aggressive form of lung cancer.

CHMP recommends approval for XOANACYL, an oral therapy for use in the following therapeutic areas: Iron deficiency, chronic renal failure and ...

Regulatory applications seeking approval for ... AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive ...

"We are of course disappointed that after this prolonged period of review the European Commission has decided to adopt the CHMP negative ... availability of data, regulatory submissions and ...