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 ...
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 ...
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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 ...
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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® (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 ...
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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 ...
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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 ...
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Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease
Eisai Europe Ltd. and Biogen Inc. announced today that a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) ...
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.
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.