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,

Business Insider · 1d

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 profound impact this medicine has had for GA patients in the U.

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.

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Henlius and Intas receive Positive CHMP Opinion for HETRONIFLY® (approved as HANSIZHUANG in China) in European markets as First-Line Treatment for adult pati…

HANSIZHUANG ® (serplulimab) was the first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC – ...

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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”) ...

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 ...

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.

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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 ...

Medindia17h

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 ...

Pharmabiz13h

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] ...

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 ...

Medscape1d

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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Bavarian Nordic Receives EMA Approval of Mpox Vaccine for Adolescents

COPENHAGEN, Denmark I 19, 2024 I Bavarian Nordic A/S (OMX: BAVA) announced today that the European Commission has adopted the Committee for ...

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