The CHMP renders a positive opinion recommending approval for BIIB and Eisai's Leqembi for treating early Alzheimer's disease ...

InflaRx (IFRX) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive ...

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

The full indication for vilobelimab is as a treatment for adult patients with SARS‑CoV-2‑induced ARDS who are receiving ...

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

EMA human medicine committee recommends approval of Sanofi’s Sarclisa to treat transplant-ineligible newly diagnosed multiple myeloma: Paris Saturday, November 16, 2024, 09:00 H ...

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 ...

EMA committee recommends approval of Eisai & Biogen’s lecanemab to treat early Alzheimer’s disease: Tokyo Saturday, November 16, 2024, 13:00 Hrs [IST] Eisai Co., Ltd. and Biog ...

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 ...

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 ...

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) -- ...