Merck Gets Positive CHMP Opinion for Keytruda in Mesothelioma
The CHMP renders a positive opinion recommending approval for MRK's Keytruda for the first-line treatment of malignant ...
CHMP Endorses J&J's Rybrevant-Lazcluze Combo for Use in NSCLC
The CHMP's opinion is based on late-stage study data, which show that treatment with JNJ's combo drug reduces the risk of ...
PharmiWeb18h
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 ...
Business Insider17h
CHMP Recommends Approval Of Lazcluze + Rybrevant In EU For EGFR-mutated Advanced NSCLC
(RTTNews) - Janssen-Cilag International NV, a Johnson & Johnson company (JNJ), Monday said that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended ...
GlobalData on MSN3d
EMA’s CHMP recommends Sanofi’s Sarclisa approval for multiple myeloma
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ...
GlobalData on MSN4d
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.
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 ...
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 ...
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 ...
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 ...
GlobalData on MSN15h
EMA’s CHMP to approve BMS’ Opdivo for colorectal cancer
Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a combination therapy consisting of ...
Bristol Myers Gets CHMP Backing for Augtyro Cancer Drug
Bristol Myers Squibb on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of its Augtyro cancer drug in a pair of indications.