pulmonary artery hypertension
EMA’s PRIME scheme launches three major new features
The scheme supports the development of treatments targeting unmet medical needs in the EU
BMS’ Opdivo gets expanded FDA and EU approval for Hodgkin lymphoma
This type of cancer is the most common one diagnosed in teenagers
Lilly announces plan for new $3bn facility to boost manufacturing in Europe
The facility will be built in the Netherlands and will increase capacity for the company's oral medicines portfolio
EU medicine shortages hit record highs in 2023 and 2024
Even with countermeasures in place, European auditors warn that the risks remain elevated
ISPOR hosts expert webinar exploring the value of ECAs for regulatory and HTA evidence needs
On Tuesday, October 7th, you are invited to join a Genesis Research Group-led webinar exploring the value of External Control Arm (ECA) studies. Gaining traction as part of evidence generation...
J&J’s Darzalex recommended by CHMP to treat smouldering multiple myeloma
If approved, Darzalex would be the first therapy approved in the EU for SMM
Organon/Henlius announce EMA validation for Perjeta biosimilar HLX11
The reference medicine holds approvals for multiple HER2-positive breast cancer indications
Rare diseases: Novartis’ Fabhalta recommended by CHMP for C3 glomerulopathy
Approximately one to two people per million worldwide are diagnosed with the ultra-rare kidney disease every year
Rare diseases: CHMP recommends Krystal’s Vyjuvek for dystrophic epidermolysis bullosa
There is currently only one treatment authorised for the ultra-rare genetic blistering disease
CHMP recommends Bavarian Nordic’s chikungunya vaccine for individuals aged from 12 years
Approximately 480,000 cases of the mosquito-borne viral disease were reported globally in 2024
Gilead’s seladelpar recommended by CHMP to treat primary biliary cholangitis
The rare liver disease affects approximately 15 per 100,000 people in Europe
GSK’s Jemperli receives positive CHMP opinion for expanded endometrial cancer use
Approximately 121,000 people are diagnosed with primary advanced or recurrent endometrial cancer each year in Europe