committee for medicinal products for human use news

Apellis Pharmaceuticals declines afters CHMP's third negative opinion on Syfovre

European regulators on Friday upheld its negative opinion on Apellis Pharmaceuticals' (NASDAQ:APLS) proposed treatment for its eye disease therapy for the third time this year. Apellis reported that the Committee for Medicinal Products for Human Use,

MarketWatch · 1d

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 second quarter.

Business Insider · 1d

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

23h

Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron KP.2-adapted COVID-19 Vaccine in the European Union

Upon authorization by the European Commission, the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and ...

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 approves Bavarian Nordic’s mpox vaccine for teenagers

The European Medicines Agency (EMA) has approved the use of Bavarian Nordic’s mpox vaccine in adolescents, increasing the ...

23h

NVO Gets Positive CHMP Opinion for Wegovy's Label Update in EU

Novo Nordisk receives a positive opinion from the CHMP for a label update of Wegovy to reflect reduced heart failure symptoms ...

Medscape1d

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.

Medindia7h

Henlius Receives Positive CHMP Opinion for HANSIZHUANG as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

HANSIZHUANG (serplulimab) is the world's first anti-PD-1 mAb for first-line treatment of ES- SCLC - HANSIZHUANG (serplulimab) is expected to become the first and only anti-PD-1 ...

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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 ...

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 ...

Pharmabiz4h

EMA committee recommends Novo Nordisk’s Wegovy label update to reflect reduced heart failure symptoms and improved physical function

Bagsværd, Denmark Saturday, September 21, 2024, 15:00 Hrs [IST] ...

Medscape20h

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 ...

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