The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the LAURA phase III trial, which were published in The ...

EMA's CHMP has recommended AstraZeneca's Tagrisso for approval in the European Union to treat individuals with NSCLC.

Bavarian Nordic, with a diverse vaccine portfolio and $340 million in contracts for 2025, offers growth potential for investors despite regulatory risks. See more.

The European Centre for Disease Prevention and Control (ECDC) said consumption of antibiotics in the EU had increased by one ...

Vir Biotechnology (VIR) “announced that the European Medicines Agency Committee for Orphan Medicinal Products, has issued a positive opinion on ...

The trial met both primary endpoints, with tirzepatide showing a 38% decrease in heart failure outcomes compared to placebo.

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 ...

Healthcare products provider RHEA Generics is committed to promoting affordable healthcare by offering generic medications ...

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 CHMP renders a positive opinion recommending approval for MRK's Keytruda for the first-line treatment of malignant ...

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