This page shows the latest EMA news and features for those working in and with pharma, biotech and healthcare.
Upon successful completion, Pfizer could submit a Biologics Licence Application (BLA) to the US Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in
Adjupanrix is a vaccine for use in adults to protect against pandemic influenza and, according to the European Medicines Agency (EMA), should only be used once an influenza pandemic has been
Earlier in July, Pfizer and BioNTech completed a submission to the European Medicines Agency (EMA) for their Omicron-adapted bivalent COVID-19 vaccine, based on the BA.1 sub-lineage, for
The Committee for Medicinal Products for Human Use (CHMP) branch of the European Medicines Agency (EMA) has recommended approval of the fixed-dose of Bristol Myers Squibb’s (BMS) Opdualag – a
AstraZeneca (AZ) has received a recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the EU approval of Tezspire (tezepelumab) as an
A marketing authorisation application (MAA) for natalizumab was accepted on 15 July 2022 by the European Medicines Agencies (EMA), as a single disease-modifying therapy (DMT) in adults with highly active
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The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are expecting a busy year for approvals, with frantic activity in orphan diseases as gene and cell therapy
Despite the global pandemic, in 2020 the European Medicines Agency (EMA) approved 39 new active substances, nine more than in 2019.
as respondents representing the FDA and EMA regional regulators.
Regulatory pressure, particularly from the FDA and more recently by the MHRA and EMA, is encouraging inclusivity and diversity, she added. ... This is a strong position to adopt and it’s good to see NICE and the EMA now want patient experience data.”.
There are more than 70 biosimilars registered in the EU, with others are under evaluation, thanks to the efforts of the European Medicines Agency (EMA) to continuously improve guidelines and provide ... The US market also has a lot of interest in
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EMA gains a new executive director, Gilead appoints a new senior vice president and BeiGene hires a new chief business exec. ... European Medicines Agency (EMA). The European Medicines Agency (EMA) management board has nominated Emer Cooke (pictured above
regional health communications campaigns. In her new role, she will leverage her expertise in FDA/EMA communications, patient and physician education, scientific communications, issues management and celebrity engagement to serve JPA
Johan Stromquist, chief executive officer, NDA Group, said: “The US expansion is our main focus in 2018 and we are planning expanding our support for FDA and EMA submissions, milestone meetings
She is the former chair of the EMA’s Committee for Advanced Therapies and comes to NDA from the Finnish Medicines Agency, where she served as a research professor.
She has an accomplished track record of working closely with the FDA and EMA on behalf of international healthcare companies to achieve key regulatory milestones.
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MAT’s Envision is the only syndicated research platform that provides forward thinking evaluations of the market access viability for a product after it has received positive EMA or FDA guidance.
Since 1989, 78 medicines have received approval on a global scale with 66 nanodrugs being approved by the FDA and 31 by the EMA.
A standardised definition for rare diseases is currently lacking, with incidences typically defined by regional legislations developed to incentivise drug development (termed ‘orphan medicines/drugs’ by the FDA and EMA).
as the European Medicines Agency (EMA) introduced “rolling reviews”, to monitor data as and when it was produced.
The recent development of several COVID-19 vaccines has placed medical research firmly in the spotlight, highlighting public confusion and misinformation about clinical trials. Patient advocate, Trishna Bharadia reveals what the life sciences
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Life is a creative communications agency offering multi-channel solutions for the healthcare industry. We use a storytelling approach to turn...