NVO Gets Positive CHMP Opinion for Wegovy's Label Update in EU
Novo Nordisk A/S NVO announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending a label update of its blockbuster weekly injection for chronic weight management,
European Drug Agency Supports Novo Nordisk's Blockbuster Weight-Loss Drug Wegovy For Obesity-Related Heart Failure
Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of Novo Nordisk A/S’ (NYSE:NVO) Wegovy (semaglutide 2.4 mg) label. The label update incorporates data showing that Wegovy,
EMA CHMP recommends label update to Novo Nordisk’s Wegovy
Committee for Medicinal Products for Human Use (CHMP) has recommended an update to Novo Nordisk’s Wegovy (semaglutide 2.4 mg) label. This update in the European Union (EU) reflects new data indicating the product’s ability,
MRNA Gets Positive CHMP Opinion for Updated COVID-19 Jab
Moderna, Inc. MRNA announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) has rendered a positive opinion recommending marketing authorization for its updated formulation of the mRNA-based COVID-19 vaccine,
Novo Nordisk’s Wegovy Gets EU Backing to Treat Obesity-Related Heart Failure
Novo Nordisk said European regulators support the use of its blockbuster weight-loss drug Wegovy to help reduce heart failure in obese patients.
Apellis Says CHMP Confirms Negative Opinion For Pegcetacoplan In Geographic Atrophy, Stock Down
Apellis Pharmaceuticals, Inc. (APLS) announced on Friday that the Committee for Medicinal Products for Human Use or CHMP of the ...
AbbVie Gets CHMP Backing for Elahere in Ovarian Cancer
Elahere, which won initial U.S. Food and Drug Administration approval in 2022 for platinum-resistant ovarian cancer, was the key asset in AbbVie's $10.1 billion acquisition of biotech ImmunoGen that ...
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EMA Broadens Imvanex Vaccine Use to Teens as Mpox Cases Rise
With more than 200 mpox-related deaths reported globally, the EMA has approved Imvanex for adolescents aged 12-17 years.
Apellis Receives Negative CHMP Opinion for Pegcetacoplan for Geographic Atrophy (GA) in the EU Following Re-Examination
This CHMP opinion was made despite broad support for pegcetacoplan from the European retina community and multiple dissenting votes by CHMP members who supported a path to approval.” “We have seen the ...
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Pfizer/BioNTech Get CHMP Nod for Omicron KP.2 EU Vaccine
Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use ...
AbbVie Receives Positive CHMP Opinion for Mirvetuximab Soravtansine (ELAHERE®) for the Treatment of Certain Adult Ovarian Cancer
AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing ...
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EMA approves Bavarian Nordic’s mpox vaccine for teenagers
Bavarian Nordic’s MVA-BN vaccine is called Imvanex in Europe but is known as Jynneos in countries such as the US and ...
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EMA’s human medicines committee elects Bruno Sepodes as new chair
EMA’s human medicines committee elects Bruno Sepodes as new chair: Amsterdam, The Netherlands Friday, September 20, 2024, ...
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Hympavzi Approved in Europe for Severe Hemophilia A and B
The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) recommended the granting of ...
Apellis: CHMP Once Again Recommends Against Syfovre
The CHMP's final opinion follows two earlier negative votes this year on the drug, which is marketed as Syfovre in the U.S. and generated $154.6 million in U.S. net product revenue for Apellis in the ...