Biogen Partner Eisai Gets Positive CHMP Nod for Leqembi in Europe
The CHMP renders a positive opinion recommending approval for BIIB and Eisai's Leqembi for treating early Alzheimer's disease ...
InflaRx receives positive CHMP opinion for GOHIBIC for SARS-CoV-2-induced ARDS
InflaRx (IFRX) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive ...
Bristol Myers receives positive CHMP opinion for repotrectinib
Squibb announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended ...
Bristol Myers gets positive EMA opinion for repotrectinib
Bristol Myers Squibb (BMY) has received a recommendation for approval from an expert panel of the European Medicines Agency ...
InflaRx Receives Positive CHMP Opinion for GOHIBIC® (Vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome
JENA, Germany, Nov. 15, 2024 (GLOBE NEWSWIRE) -- (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory ...
Medscape20h
EMA Recommends Vilobelimabfor ARDS Induced by SARS-CoV-2
The full indication for vilobelimab is as a treatment for adult patients with SARS‑CoV-2‑induced ARDS who are receiving ...
Medscape20h
Leqembi Okayed for Subset of Early Alzheimer’s Patients
The European Medicines Agency re-examined clinical data of a subset of patients with one or no copies of the APOE4 gene ...
Pharmabiz10h
EMA human medicine committee recommends approval of Sanofi’s Sarclisa to treat transplant-ineligible newly diagnosed multiple myeloma
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 ...
PharmiWeb19h
Aflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA
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 ...
FiercePharma23h
EU regulators endorse meds from BMS, J&J, Eisai and more—plus a clutch of biosims
Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.
Pharmabiz6h
EMA committee recommends approval of Eisai & Biogen’s lecanemab to treat early Alzheimer’s disease
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 ...
InflaRx receives positive CHMP opinion for SARS-CoV-2-induced acute respiratory distress treatment
InflaRx N.V.  (NASDAQ:IFRX) announced Friday that an expert panel of the EU drug regulator, the European Medicines Agency (EMA), endorsed vilobelimab for SARS-CoV-2-induced acute respiratory distress.