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EMA

Norgine submits Marketing Authorisation Application to the European Medicines Agency for eflornithine (difluoromethylornithine [DFMO]) in high-risk neuroblastoma

Norgine HRNB EMA

Norgine today announced that it completed its marketing authorisation application filing to European Medicines Agency (EMA) for eflornithine in high-risk neuroblastoma (HRNB).

January 7, 2025 by PRNewswire

New regulations in the Year 2023 for different regulatory bodies around the world

drug regulations FDA EMA GMP Australia

This article will explore new regulations in countries like the United States, Europe, Japan, and Australia.

January 23, 2024 by Muhammad Asim Niazi

Drug Marketing in China and Worldwide (July)

FDA NMPA EMA Drug Listing

On July 6th, Eisai's lecanemab (Leqembi) was fully approved by the FDA for the treatment of Alzheimer's disease

August 11, 2023 by Caicai/PharmaSources

EMA regulation and response to drug shortages

Drug Shortages EMA

The EMA has established an agency called the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to address drug shortages.

June 12, 2023 by PharmaSources/zhulikou431

Why Drug regulatory authority updates their Rules and Regulations

Drug review EMA FDA

Pharmaceutical regulatory authorities regularly update their rules and regulations regarding drug review and approval.

March 21, 2023 by Muhammad Asim Niazi

Pharma Co-packaging Regulations

NMPA FDA EMA Co-packaging Regulations

Let’s discuss some regulatory requirements for contract packaging in line with three most competitive markets i.e China , United States and Europe.

March 21, 2023 by Muhammad Asim Niazi

New regulation strengthens role of EMA in EU crisis response

EMA COVID-19 pandemic

NEWS New regulation strengthens role of EMA in EU crisis response The regulation sees tools, structures and processes set up by EMA during the pandemic to accelerate clinical trial approval and regulatory assessments in the EU being formally recognised.

February 9, 2022 by EuropeanPharmaceuticalReview

Drugmakers Meet With EMA on Vaccines Targeting Omicron

EMA Omicron vaccine

The European Medicines Agency (EMA) is meeting with four leading COVID-19 vaccine makers to discuss potential trials for shots targeting the fast-spreading Omicron variant, as reported in the Financial Post.

January 11, 2022 by FirstWordPharma

Pfizer’s Paxlovid™ can be used for the treatment of COVID-19, says EMA

EMA COVID-19 Paxlovid

New European Medicines Agency advice states Paxlovid™ can be used to treat those at high risk of developing severe COVID-19 symptoms.

December 21, 2021 by EuropeanPharmaceuticalReview

EMA CHMP advises use of Pfizer’s Covid-19 oral antiviral Paxlovid

EMA CHMP Paxlovid

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the usage of Pfizer’s oral antiviral, Paxlovid (nirmatrelvir plus ritonavir), to treat adult Covid-19 patients.

December 20, 2021 by Pharmaceutical-Technology

EMA initiates rolling review of Valneva’s COVID-19 vaccine (VLA2001)

EMA VLA2001 vaccine

The European Medicines Agency (EMA)’s human medicines committee (CHMP) has begun a rolling review of VLA2001, a COVID-19 vaccine being developed by Valneva...

December 6, 2021 by EuropeanPharmaceuticalReview

EMA receive marketing authorisation application for molnupiravir

EMA molnupiravir COVID-19

The use of molnupiravir in COVID-19 cases aims to reduce the pressure on hospitals, in turn reducing the risk of patients developing more severe symptoms of the virus.

November 26, 2021 by PharmaTimes