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 ...
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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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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 ...
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Merck Gets Positive CHMP Opinion for Keytruda in Mesothelioma
Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion, recommending the approval of its ...
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 ...
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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.
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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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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 ...