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 · 16h

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 · 16h

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.

Zacks.com on MSN12h

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”) ...

Medscape10h

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 ...

15h

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 ...

15h

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 ...

Medscape17h

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.

Zacks.com on MSN14d

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 ...

Pharmabiz18h

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, ...

15h

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 ...

Armed robbery in Revesby13h

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 ...

Pharmaceutical Technology on MSN8h

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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