A new study reveals that more than half of cancer drugs approved by the FDA under accelerated pathways are not authorized in ...

InflaRx (IFRX) has released an update. InflaRx has received a positive opinion from the European Medicines Agency’s CHMP for GOHIBIC, a ...

Lecanemab is the first treatment for Alzheimer’s disease licensed for use in Great Britain that shows some evidence of ...

Patients with MSI-high/dMMR advanced colorectal cancers had a 79 percent lower risk of disease progression or death on Opdivo-Yervoy compared to chemo.

Aflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA ...

Two kinase inhibitors have been recommended by the European Medicines Agency for the treatment of non-small cell lung cancer.

Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.

Bristol Myers Squibb (BMY) has received a recommendation for approval from an expert panel of the European Medicines Agency ...

InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the Committee for Medicinal Products for Human ...

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ...

A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.

Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.