Acoramidis Receives Positive CHMP Opinion for Treatment of Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of acoramidis in the EU based on ...
Gilead’s Seladelpar Receives Positive CHMP Opinion for Primary Biliary Cholangitis
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the ...
Lilly Gets Positive CHMP Opinion For Omvoh In Crohn's Disease
(RTTNews) - Eli Lilly and Company (LLY) Friday said that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Omvoh for the treatment ...
BridgeBio Pharma Announces CHMP's Positive Recommendation Of Acoramidis - Quick Facts
BridgeBio Pharma (BBIO) announced the Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion ...
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CHMP Recommends Approval of Galderma's Nemolizumab for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis in the European Union
Galderma today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting the marketing ...
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Aurobindo Pharma arm CuraTeQ gets European body's nod for filgrastim biosimilar
The CHMP recommendation is a critical step towards obtaining marketing authorisation for filgrastim biosimilar Zefylti in the ...
Lilly's Mounjaro does not need separate indication for sleep apnea, EMA panel determines
Stock Editorial via Getty Images An expert panel of the EU drug regulator, the European Medicines Agency (EMA), has ...
Gilead Gets Key European Backing for Liver-Disease Treatment
The U.S. Food and Drug Administration in August granted accelerated approval to seladelpar, which the Foster City, Calif., company markets as Livdelzi. The drug was the key asset in Gilead's $4.3 ...
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Eli Lilly Gets Key European Backing for Omvoh in Crohn's Disease
Eli Lilly on Friday said the recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use covers Omvoh for the treatment of adults with moderately to severely ...
Merck & Co. Gets Key European Backing for Welireg in Two Uses
Merck & Co. said a key European regulatory committee has recommended conditional approval of its Welireg oral cancer drug in a pair of indications.
Novo Nordisk's Ozempic Label Expansion Snags Approval From European Drug Regulator's Advisory Panel
Novo Nordisk's Ozempic gains positive EMA opinion for label update after FLOW trial data show significant kidney and ...
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Geron Announces Positive CHMP Opinion for RYTELOtm (imetelstat) for the Treatment of Adults with Transfusion-Dependent Anemia due to Lower-Risk MDS
Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced that the Committee for Medicinal Products ...