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 · 18h

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 · 18h

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.

PharmiWeb16d

EMA Committee for Medicinal Products for Human Use…

Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for an updated formulation of the COVID-19 mRNA vaccine Spikevax, ...

PipelineReview.com22h

BAGSVAERD, Denmark I 19, 2024 I Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human ...

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

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval ...

17h

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 ...

Medscape20h

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.

14h

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 ...

Armed robbery in Revesby15h

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 ...

Pharmabiz1h

EU drug regulator approves use of Bavarian Nordic's mpox vaccine, Imvanex for adolescents

EU drug regulator approves use of Bavarian Nordic's mpox vaccine, Imvanex for adolescents: Copengagen, Denmark Saturday, September 21, 2024, 10:00 Hrs [IST] Bavarian Nordic A/S, a ...

Medscape12h

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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