PharmiWeb41m
Formycon receives positive CHMP opinion for FYB203…
Statement/Regulatory AdmissionFormycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama® 18.11.2024 / 06:30 ...
GlobalData on MSN2d
EMA’s CHMP recommends Sanofi’s Sarclisa approval for multiple myeloma
Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi’s Sarclisa combined with Velcade ...
Pharmabiz3h
EMA committee recommends approval of Bristol Myers’ repotrectinib to treat advanced ROS1-positive NSCLC & NTRK-positive solid tumours
EMA committee recommends approval of Bristol Myers’ repotrectinib to treat advanced ROS1-positive NSCLC & NTRK-positive solid tumours: Princeton, New Jersey Monday, November 18, ...
InflaRx Receives Positive CHMP Opinion for GOHIBIC® (Vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome
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 ...
Bristol Myers gets positive EMA opinion for repotrectinib
Bristol Myers Squibb (NYSE:BMY) has received a recommendation for approval from the Committee for Medicinal Products for ...
GlobalData on MSN3d
EMA rethinks stance, committee now recommends Leqembi for Alzheimer’s disease
Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.
European committee takes a second look at Alzheimer's drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
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 ...
Daily20h
Sarclisa recommended for EU approval by CHMP to treat transplant-ineligible newly diagnosed multiple myeloma: Sanofi
Paris: Sanofi has announced that the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) ...
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 ...
Medscape2d
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 ...
Seattle Times3d
European committee takes a second look at Alzheimer’s drug and now says it should be approved
Biogen said Thursday that the drug, known in the U.S. as Leqembi, received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use as a treatment ...