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The Latest Breaking News from Committee for Medicinal Products for Human Use

Sanofi's Rezurock Approval Stumbles In EU For Chronic Graft-Vs-Host Disease

On Friday, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for Sanofi SA’s (NASDAQ:SNY) Rezurock (belumosudil).

Eli Lilly's Early Alzheimer's Drug Recommended For Approval By European Drug Regulator's Panel

Eli Lilly's Early Alzheimer's Drug Recommended For Approval By European Drug Regulator's Panel

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Friday recommending Eli Lilly and Co.’s (NYSE:LLY) donanemab for early symptomatic Alzheimer’s disease in adults with confirmed amyloid pathology who are apolipoprotein E ε4 (ApoE4) heterozygotes or non-carriers.

EMA's Advisory Committee Recommends Eiger's Zokinvy In Premature Aging Disorder

EMA's Advisory Committee Recommends Eiger's Zokinvy In Premature Aging Disorder

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending Eiger BioPharmaceuticals Inc's (NASDAQ:EIGR) Zokinvy for Hutchinson-Gilford progeria syndrome (HGPS) and processing-deficient progeroid laminopathies (PL). HGPS and PL are ultra-rare and fatal pediatric diseases that cause dramatically accelerated aging and premature death. The CHMP…

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EMA' Advisory Committee Recommends Approval For Roche's Two Cancer Drugs

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended conditional approval for Roche Holdings AG's (OTC:RHHBY) mosunetuzumab for relapsed or refractory (R/R) follicular lymphoma (FL). The opinion covers mosunetuzumab for adult patients who have received at least two prior systemic therapies. The CHMP recommendation is based on…

Calliditas Expects EMA's CHMP Opinion For Nefecon In Q2

Calliditas Therapeutics AB (NASDAQ:CALT) says that the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) can be expected in Q2 of 2022. In its review of the marketing authorization application (MAA) for Nefecon, the CHMP has informed us that they will issue an…

EMA's Advisory Committee Does Not Back Orphazyme's Arimoclomol Application

Orphazyme A/S (NASDAQ: ORPH) has been notified by the Committee for Medicinal Products for Human Use (CHMP) of a

EMA's Advisory Committee Recommends Approval Of Blueprint Medicines' Avapritinib In Blood Disorder

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has

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CHMP Recommends Pfizer's Paxlovid For Use In Adults With COVID-19

CHMP Recommends Pfizer's Paxlovid For Use In Adults With COVID-19

The European Medicines Agency's Committee for Medicinal Products for Human Use has

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European Medicines Agency

Eli Lilly And Co

Blueprint Medicines

Roche Holdings AG

The European Medicines Agency

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