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European Medicines Agency

Moderna’s updated Covid-19 vaccine receives positive EMA CHMP opinion Pharmaceutical Business Review11:55Moderna Vaccine Coronavirus Vaccine CHMP

MRNA gets positive CHMP opinion for updated COVID-19 jab Zacks14:08Moderna Vaccine Coronavirus Vaccine CHMP

SeaBeLife receives Orphan Drug Designation from EMA for acute liver failure treatment European Pharmaceutical Manufacturer16:08SeaBeLife Biotechnology Pharma

SeaBeLife's SBL01 acute liver failure drug candidate receives ODD from the EMA Manufacturing Chemist10:30SeaBeLife Biotechnology Pharma

EU auditors criticise the response of health agencies to COVID EurActiv.com13:24Covid Pandemics

ECA: Europeans - Astra Zeneca and Pfizer guinea pigs in the case of anti-Covid 19 vaccines Bursa.ro22:08Covid Pandemics

'Tofu-like' psychedelic gets FDA nod - Mindstate's AI-designed therapy to begin human trials Benzinga14:12FDA Pharma IT

EMA accepts marketing authorization application for alvotech’s AVT06 (aflibercept) JD Supra19:07

Bristol Myers Squibb’s CAR T-cell therapy Breyanzi receives application validation from the EMA Manufacturing Chemist09:45Bristol Myers Squibb T-Cells Pharma

Bristol Myers' (BMY) Breyanzi label expansion application validated Zacks18:32Bristol Myers Squibb T-Cells Pharma

EMA accepts marketing application for t-DXd in HER2-Low and -Ultralow metastatic breast cancer OncLive16:41Breast Cancer Cancer Type II Variation

EMA validates Type II Variation application for ENHERTU for breast cancer treatment Pharmaceutical Business Review12:20Breast Cancer Cancer Type II Variation

Latest News

In the last 7 days

MRNA Gets Positive CHMP Opinion for Updated COVID-19 Jab Zacks14:08 6-Sept-24

Moderna’s updated Covid-19 vaccine receives positive EMA CHMP opinion Pharmaceutical Business Review11:55 6-Sept-24

'Tofu-Like' Psychedelic Gets FDA Nod - Mindstate's AI-Designed Therapy To Begin Human Trials Benzinga14:12 5-Sept-24

EU auditors criticise the response of health agencies to COVID EurActiv.com13:24 5-Sept-24

ECA: Europeans - Astra Zeneca and Pfizer guinea pigs in the case of anti-Covid 19 vaccines Bursa.ro22:08 4-Sept-24

SeaBeLife receives Orphan Drug Designation from EMA for acute liver failure treatment European Pharmaceutical Manufacturer16:08 4-Sept-24

SeaBeLife's SBL01 acute liver failure drug candidate receives ODD from the EMA Manufacturing Chemist10:30 3-Sept-24

In the last month

FDA Grants Priority Review to SpringWorks Therapeutics’ New Drug Application for Mirdametinib for the Treatment of… GlobeNewswire (Press Release)11:34 28-Aug-24

EMA Accepts Marketing Authorization Application for Alvotech’s AVT06 (aflibercept) JD Supra19:07 27-Aug-24

Avanzanite Bioscience Reports European Commission's Authorisation of Orphan Medicinal Product… Business Wire (Press Release)06:01 27-Aug-24

Pentixapharm AG Receives Orphan Drug Designation for its Radiodiagnostic Tracer PentixaFor in… DGAP15:34 26-Aug-24

Bristol Myers' (BMY) Breyanzi Label Expansion Application Validated Zacks18:32 20-Aug-24

Bristol Myers Squibb’s CAR T-cell therapy Breyanzi receives application validation from the EMA Manufacturing Chemist09:45 20-Aug-24

Improving the FDA-EMA parallel scientific advice program to advance complex generics STAT09:42 20-Aug-24

EMA Expands Indication for Bristol Myers Squibb Follicular Lymphoma Therapy PharmTech.com18:18 19-Aug-24

EMA Accepts Marketing Application for T-DXd in HER2-Low and -Ultralow Metastatic Breast Cancer OncLive16:41 19-Aug-24

EMA Validates Application for Liso-Cel in Relapsed/Refractory Follicular Lymphoma OncLive16:10 19-Aug-24

EMA validates Type II Variation application for ENHERTU for breast cancer treatment Pharmaceutical Business Review12:20 19-Aug-24

European Medicines Agency Validates Bristol Myers Squibb’s Application for CAR T Cell Therapy… Business Wire (Press Release)12:01 19-Aug-24

ENHERTU® Type II Variation Application Validated by EMA for Patients with HER2 Low or HER2… Business Wire (Press Release)07:06 19-Aug-24

Bavarian Nordic seeks crucial EU approval for Mpox vaccine for teens Invezz15:39 16-Aug-24

Bavarian Nordic Submits Data To EMA To Approve Use Of Mpox/Smallpox Vaccine In Adolescents RTT News07:44 16-Aug-24

U.S. Food and Drug Administration Accepts for Priority Review Deciphera’s New Drug Application… Business Wire (Press Release)23:05 15-Aug-24

KalVista Announces Validation of Marketing Authorization Application by the European Medicines… Business Wire (Press Release)11:32 15-Aug-24

European Medicines Agency Confirms Acceptance of Marketing Application for AVT06, a Proposed Biosimilar to Eylea®… GlobeNewswire (Press Release)09:30 15-Aug-24

Veralox Therapeutics Announces EMA Orphan Drug Designation for VLX-1005 GlobeNewswire (Press Release)12:31 14-Aug-24

Bavarian Nordic Announces FDA Acceptance and Priority Review of the BLA for its Chikungunya Vaccine GlobeNewswire (Press Release)18:47 13-Aug-24

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6 Sept 14:08

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About our EMA news

Latest news on the European Medicines Agency, also known as the EMA, a European Union agency responsible for the evaluation and supervision of pharmaceuticals.

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