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CHMP Adopted Positive Opinion for ELZONRIS (tagraxofusp), for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
prnasia
November 18, 2020
The Menarini Group, a privately held Italian pharmaceutical and diagnostics company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the approval of ..
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CHMP recommends five medicines for approval in latest meeting
europeanpharmaceuticalreview
November 17, 2020
The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
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Six new medicines leap towards EU approval
pharmatimes
November 17, 2020
The EMA’s human medicines committee (CHMP) recommended six medicines for approval at its November 2020 meeting.
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EMA recommends 10 medicines for approval in October meeting
europeanpharmaceuticalreview
October 23, 2020
Ten medicines have been recommended for marketing authorisation and 10 extensions of indication have been suggested by the EMA.
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CHMP recommends AstraZeneca’s Forxiga for approval in EU
pharmaceutical-technology
October 21, 2020
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended AstraZeneca’s Forxiga (dapagliflozin) for an indication extension of its marketing authorisation in the European Union (EU).
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Ten new medicines backed for EU approval
pharmatimes
October 21, 2020
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended ten new medicines for approval at its October 2020 meeting.
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Pacira Receives Positive CHMP Opinion for EXPAREL for Postsurgical Pain
americanpharmaceuticalreview
September 27, 2020
Pacira BioSciences announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for EXPAREL for postsurgical analgesia.
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CHMP backs seven new meds in September meeting
pharmatimes
September 22, 2020
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for approval in its latest meeting.
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CHMP advises approval for Bristol Myers Squibb’s Opdivo plus Yervoy with chemo for metastatic NSCLC
expresspharma
September 21, 2020
The European Commission will now review the CHMP recommendation.
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Imfinzi Recommended for Approval by CHMP for Small Cell Lung Cancer
americanpharmaceuticalreview
August 03, 2020
AstraZeneca’s Imfinzi (durvalumab) has been recommended for marketing authorization in the European Union (EU) for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies ...