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NVO Gets Positive CHMP Opinion in EU for Ozempic Expanded Use in CKD
Novo Nordisk NVO announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...
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 positive results from the ...
Geron Announces Positive CHMP Opinion for RYTELO™ (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 ...
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 ...
Medscape21h
Self-Replicating mRNA Vaccine for COVID Prevention
Europe's Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for two drugs for ...
Merck gets positive EU regulatory opinion for Welireg
The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending ...
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 ...
CSL Receives Positive CHMP Opinion for Garadacimab in Hereditary Angioedema (HAE)
Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the European Medicines Agency's (EMA) Committee for ...
Business Wire15h
CHMP Recommends Approval of Galderma’s Nemolizumab for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis in the European Union
CHMP Recommends Approval of Galderma’s Nemolizumab for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis in the European Union ...
Medscape5h
Emcitate Recommended for Peripheral Thyrotoxicosis in AHDS
Allan-Herndon-Dudley syndrome is caused by mutations in the gene coding for a thyroid hormone transporter, preventing thyroid ...
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.
Business Insider15h
BridgeBio receives positive CHMP opinion for acoramidis for ATTR-CM treatment
BridgeBio Pharma (BBIO) announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization in the European Union for acoramidis for ...