Sanofi SNY announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion recommending the approval of its blood cancer drug, ...

Novo Nordisk NVO announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that Ozempic’s (once-weekly ...

The company formerly known as BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) has ...

Lilly's Kisunla gets FDA approval for a new dosing schedule that significantly lowers ARIA-E risk while maintaining amyloid ...

The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be approved in combination with bortezomib, lenalidomide and dexamethasone (VRd) as an induction treatment for ...

The CHMP has backed approval of Tecvayli for adults with relapsed and refractory multiple myeloma who have received at least three prior therapies – including an immunomodulatory agent, ...

CHMP adopts positive opinion for the marketing authorisation of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer ...

An EMA committee has recommended approval of Alvotech’s AVT06, a biosimilar to Bayer’s blockbuster ophthalmology drug Eylea.

Biocon Biologics’ Denosumab biosimilars, Vevzuo and Evfraxy, have received marketing authorisation in the European Union (EU).

Denosumab biosimilars Vevzuo and Evfraxy are used for treating various bone diseases. The approvals mark a key step in the ...

CuraTeQ Biologics, a unit of Aurobindo Pharma, has received EU approval to market Dazublys, its trastuzumab biosimilar for ...

Madrigal Pharma's REZDIFFRA sees 33% Q1 2025 sales growth, strong EU progress, and promising MASH data. Read why I maintain my Hold rating on MDGL stock.