European Medicines Agency and other governmental regulations applicable to product approvals; changes in the regulatory ...

OBODENCE™ and XBRYK™ recommended for approval by the European Medicines Agency for all indications referencing Prolia and Xgeva, respectively INCHEON, South Korea, Nov. 15, 2024 (GLOBE NEWSWIRE) -- ...

Presented positive interim data for 4D-150 in wet age-related macular degeneration (wet AMD) from PRISM Phase 1/2 clinical trial highlighting robust and durable clinical activity across diverse patien ...

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 US Food and Drug Administration approved Augtyro in 2023 for the treatment of ROS1-positive advanced NSCLC. Earlier this year, the FDA also approved the drug for adult and pediatric patients 12 ...

EMA's human medicines committee issued positive recommendations for multiple drugs, including Merck's Keytruda and InflaRx's ...

Statement/Regulatory AdmissionAflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA15-Nov-2024 / 18:18 CET/CESTDisclosure of an inside information acc. to Article ...

The first drug targeting the root cause of Alzheimer’s disease has been approved by the European Medicines Agency. Despite ...

The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November ...

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

Merck (MRK) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, adopted an opinion ...

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