[ad_1] — For the first time, the estimated 40,000 patients with indolent SM in the EU1,2* would have a medicine that treats the primary disease driver3,4 — — Opinion based on the…
Tag: CHMP
Mirati Therapeutics Receives Positive Opinion from CHMP for KRAZATI (adagrasib) as a Targeted Treatment Option for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation Following a Re-Examination Procedure
[ad_1] SAN DIEGO, Calif. and ZUG, Switzerland, Nov. 10, 2023 /PRNewswire/ — Mirati Therapeutics, Inc.® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced that following a re-examination procedure, the…
Astellas Receives Positive CHMP Opinion for VEOZA™ (fezolinetant)
[ad_1] Fezolinetant is an investigational nonhormonal treatment for vasomotor symptoms (VMS) associated with menopause More than half of women ages 40 to 64 worldwide experience VMS, with rates in Europe…
CHMP Adopts Positive Opinion to Extend the Use of Veklury® (Remdesivir) to Treat COVID-19 in People With Hepatic Impairment
[ad_1] — This Positive Opinion Reinforces Veklury’s Strong Safety Profile — FOSTER CITY, Calif.–(BUSINESS WIRE)– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human…
Ascendis Pharma Receives Positive CHMP Opinion for TransCon™ PTH (palopegteriparatide) for Adults with Chronic Hypoparathyroidism
[ad_1] – Final European Commission decision expected within 67 days after positive opinion; if approved, first European Union launch planned in Germany in early 2024 COPENHAGEN, Denmark, Sept. 14, 2023…