The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently refused marketing authorization for Nezglyal (leriglitazone).
In 2022, the European Medicines Agency (EMA) recommended 89 medicines for marketing authorization: including six advanced therapy medicinal products and eight biosimilars.
The European Medicines Agency (EMA) is planning to alert healthcare professions about liver failure cases linked to Zolgensma, a gene therapy against spinal muscular atrophy (SMA), which is developed by Novartis.
The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) are collaborating on vaccine safety and effectiveness monitoring studies.
The European Medicines Agency (EMA) will provide up to five selected advanced therapy medicinal products (ATMPs) with enhanced regulatory support - and in the process hopes to learn how to improve the regulatory processes for other ATMP drugs in the future.
Charles River Laboratories, International Inc. has received regulatory approval - in the form of Good Manufacturing Practice (GMP) certification - to commercially produce allogeneic cell therapy drug products for distribution in Europe, from the European...
Polpharma Biologics’ Marketing Authorization Application for natalizumab – a proposed biosimilar to Biogen’s Tysabri – has been accepted by the European Medicines Agency (EMA).
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) made several recommendations for approval of drugs and therapies at its June 2022 meeting.
Biogen has withdrawn its Marketing Authorization Application for Aduhelm (aducanumab) for the treatment of the early stages of Alzheimer’s disease in the EU.
Janssen’s Carvykti, a therapy for multiple myeloma, has been approved for conditional marketing authorization (CMA) by the European Medicines Agency (EMA).
Biogen will ask the European Medicines Agency (EMA) to re-examine its Alzheimer’s drug application, following the agency’s recommendation to refuse authorization of the drug in the EU.
The EMA has validated Atara Biotherapeutics' Marketing Authorization Application (MAA) for tabelecleucel (tab-cel), the first time an off-the-shelf allogeneic T-cell therapy will be evaluated by any regulatory agency in the world.
The European Medicine Agency’s human medicines committee (CHMP) says that booster doses of the Pfizer/BioNTech vaccine may be considered in people aged 18+, although decisions on who is offered a booster will be made at a national level.
The EU Commission has extended vaccination with Moderna’s COVID-19 vaccine to adolescents, following on from the EMA's recommendation in relation to the use of the shot in children aged between 12 and 17.
German company, CureVac, says it is in ongoing dialogue with the European Medicines Agency (EMA) and is continuing regulatory submissions on its first-generation mRNA COVID-19 vaccine candidate, CVnCoV.
The partners announce the addition of a manufacturing facility that will become the fourth in Legend’s network. It is expected to be operational by 2023.
Decentralized trials and remote monitoring, long discussed, but never really taking off until COVID-19 disrupted studies last year, will be under the spotlight at the DIA 2021 Annual Meeting at the end of this month.
The European Medicines Agency’s safety committee, PRAC, has concluded there is a possible link between the use of AstraZeneca’s COVID-19 vaccine and rare side effects of unusual blood clots and low blood platelets in individuals who received the shot.
The EU has approved new storage conditions for Pfizer/BioNTech’s vaccine: allowing the ultra-cold storage vaccine to now be kept at standard pharmaceutical freezer temperatures for a total of two weeks.
The European Medicine Agency (EMA) says its safety committee has ruled that COVID-19 Vaccine AstraZeneca is safe and effective, and the benefits of its use outweigh any possible risks.
The European Medicines Agency (EMA) has started a rolling review of Sputnik V, a COVID-19 vaccine developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology.
The European Medicines Agency (EMA) has published guidance outlining the regulatory requirements for manufacturers planning to modify their COVID-19 vaccines against SARS-CoV-2 variants.
German officials are not recommending the use of the AstraZeneca-Oxford University COVID-19 vaccine on people aged over 65, according to a report in the Financial Times.
Pfizer/BioNTech and Moderna have each submitted formal applications for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their COVID-19 vaccines: completing the rolling review process.
A new multi-stakeholder group of experts has been set up to provide input and ideas in the context of the ongoing evaluation of the orphan medicinal products (OMP) regulation in Europe.
The EMA looks to the future by posting its five key priorities to address in the coming five years, which includes the need to recruit expertise in ‘novel manufacturing technologies’.
Bluebird has received EU conditional marketing approval for patients with transfusion-dependent β-thalassemia, becoming the first treatment from its pipeline to receive approval.
MSD announced that the EMA’s CHMP has adopted a positive opinion recommending approval of Keytruda as an adjuvant therapy for the treatment of patients with melanoma.
It has been revealed that the EMA is awarding significantly fewer contracts to evaluate the application of new drugs to the MHRA, as the Brexit deadline nears.
BioIndustry Association, a trade organisation for bioindustry, has voiced its frustration at the lack of clarity facing those in the industry over Brexit.
Drug firms’ pre-submission meetings with the EMA may influence agency approval decisions according to European Ombudsman Emily O' Reilly who has launched an investigation
