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 ...

One of the primary challenges in the regulatory affairs of the pharmaceutical industry is keeping pace with the ever-evolving regulatory landscape.

If approved by the EC, Tagrisso will be the first targeted therapy for European patients with unresectable EGFR-mutated cancer.

The European Union health agency on Monday warned that Europe was set to miss goals on reducing the use of antibiotics, ...

That Thursday, for the first time, the European Medicines Agency (EMA) approved a drug that targets the cause — not just the ...

Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion, recommending the approval of its ...

The study showed significant reductions in serum TTR levels in subjects after a single dose, with sustained effects over time ...

The approval in Europe was expected as in September the European Medicines Agency's (EMA) Committee for Medicinal Products ...

(RTTNews) - Janssen-Cilag International NV, a Johnson & Johnson company (JNJ), Monday said that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended ...

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

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.

The European Medicines Agency re-examined clinical data of a subset of patients with one or no copies of the APOE4 gene ...