Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G) Fabhalta is the only oral alternative complement pathway ...

The combination of Opdivo plus Yervoy was granted accelerated approval by the U.S. FDA in 2020 as a second-line treatment for patients with advanced HCC based on Phase 2 CheckMate -040 trial results.

Mounjaro (tirzepatide) is a prescription drug that may be prescribed off-label for weight loss. The drug isn’t approved for this use, but it may be helpful for weight management. Mounjaro comes ...

Via early access, an individual healthcare system can support and fund treatment before European Medicines Agency (EMA) approval. As many as 18 European countries follow their own national procedures ...

AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been recommended for approval in the European Union ... for Medicinal Products for Human Use (CHMP) of the European Medicines ...

A durvalumab (Imfinzi)-based perioperative regimen has been recommended by the EMA Committee for the treatment of adults ... in combination with chemotherapy has been recommended for approval in the ...

AbbVie announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (Rinvoq; 15 mg, once ...

of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of a label extension for IXCHIQ ®, Valneva’s single-dose vaccine for the prevention of disease caused ...

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three novel medicines for approval at its February 2025 meeting. The European Commission is expected to announce a ...

of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of a label extension for IXCHIQ ®, Valneva's single-dose vaccine for the prevention of disease ...