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European Medicines Agency

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EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine PMLiVE12:09Valneva Coronavirus Vaccine European Commission
Dynavax (dvax) up as EMA accepts Valneva's COVID-19 vaccine MAA Nasdaq19:19Valneva Coronavirus Vaccine European Commission
Calliditas Therapeutics shares rise 18% after chmp approval for Kinpeygo MarketWatch17:24
Calliditas Therapeutics gets chmp approval for Kinpeygo MarketWatch14:21
EU regulator aims to approve vaccines adapted to new COVID-19 variants by September Anadolu Agency16:09Covid Vaccine Boosters Coronavirus Vaccine AZ Vaccine
EU health regulator backs using AstraZeneca Covid shot as booster Yahoo! UK & Ireland16:50Covid Vaccine Boosters Coronavirus Vaccine AZ Vaccine
Oman to fast-track nods to Indian pharma products registered by US, UK, Europe The Economic Times17:50Oman India Middle East
Oman to fast-track approval of Indian pharma products registered by USFDA, Ukmhra, EMA The Times of India16:57Oman India Middle East
PTC's first gene therapy gains European regulator's backing BioPharma Dive17:19Pharma
Roche Pharma launches drug to treat breast cancer The Times of India14:01Pharma FDA India
Positive scientific opinion from EMA on human insulin with more flexible storage without… The Daily Star, Bangladesh20:08Insulin
Instem secures European Medicines Agency research grant London South East13:01Instem
Instem research consortium lands €2.5mln European Medicines Agency grant Proactive Investors (UK)07:50Instem
Mirati Therapeutics submits marketing authorization application to the European Medicines Agency for investigational… BioSpace03:38FDA Pharma
European approval sought for adagrasib in previously treated kras G12C–mutated nsclc OncLive19:57Lung Cancer Cancer

Latest News

In the last 7 days
European Approval Sought for Adagrasib in Previously Treated KRAS G12C–Mutated NSCLC OncLive19:57 20-May-22
Dynavax (DVAX) Up as EMA Accepts Valneva's COVID-19 Vaccine MAA Nasdaq19:19 20-May-22
PTC's first gene therapy gains European regulator's backing BioPharma Dive17:19 20-May-22
Novartis Cosentyx® (secukinumab) receives positive CHMP opinion for expanded use in childhood arthritic conditions Novartis (Press Release)13:52 20-May-22
First therapy to treat two types of Niemann-Pick disease, a rare genetic metabolic disorder European Medicines Agency13:09 20-May-22
First therapy to treat rare genetic nervous system disorder AADC deficiency European Medicines Agency13:09 20-May-22
First treatment for children with Progeria or progeroid like syndromes (rare premature aging syndromes) European Medicines Agency13:09 20-May-22
Synchron Research Service: suspension of medicines over flawed studies European Medicines Agency12:59 20-May-22
EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine PMLiVE12:09 20-May-22
Media Update: CHMP recommends approval of Xenpozyme® (olipudase alfa), the first and only treatment for ASMD Sanofi (Press Release)06:14 20-May-22
Mirati Therapeutics Submits Marketing Authorization Application to the European Medicines Agency for Investigational… BioSpace03:38 20-May-22
Why Dynavax Stock Blasted 16% Higher Today Nasdaq23:48 19-May-22
Calliditas Therapeutics Shares Rise 18% After CHMP Approval for Kinpeygo MarketWatch17:24 19-May-22
EU health regulator backs using AstraZeneca Covid shot as booster Yahoo! UK & Ireland16:50 19-May-22
Calliditas Therapeutics Gets CHMP Approval for Kinpeygo MarketWatch14:21 19-May-22
Calliditas receives positive CHMP opinion in IgA nephropathy BioSpace14:05 19-May-22
Valneva says the European Medicines Agency accepted application for its COVID-19 vaccine MarketWatch13:53 19-May-22
EMA accepts filing of marketing authorization application for Valneva’s inactivated COVID-19 Vaccine Candidate Valneva (Press Release)06:02 19-May-22
Tetra Bio-Pharma Receives EMA Orphan Drug Designation for a Novel Topical Therapeutic… PR Newswire (Press Release)13:06 18-May-22
Valneva (VALN) Down as EU Considers Ending COVID-Vaccine Deal Nasdaq20:27 17-May-22
EU may terminate vaccine purchase agreement with French drugmaker Valneva EurActiv.com19:59 17-May-22
EU sets out intention to terminate COVID-19 vaccine deal with Valneva Biopharma Reporter15:19 16-May-22
EC to terminate Covid-19 vaccine deal with Valneva Pharmaceutical Technology12:27 16-May-22
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022 European Medicines Agency08:35 16-May-22
In the last month
Gerrit Johan Schefferlie elected new Chair of EMA Committee for Medicinal Products for Veterinary Use (CVMP) European Medicines Agency14:49 13-May-22
Gerrit Johan Schefferlie elected new Chair of EMA Committee for Veterinary Medicinal Products (CVMP) European Medicines Agency13:53 13-May-22
Meeting of Heads of Agency (HMA) from 4 to 6 May 2022 ANSES14:01 12-May-22
Roche Pharma launches drug to treat breast cancer The Times of India14:01 12-May-22
Unlearn Receives Draft Qualification Opinion from European Medicines Agency for Using the… Business Wire (Press Release)13:02 12-May-22
Oman to fast-track nods to Indian pharma products registered by US, UK, Europe The Economic Times17:50 11-May-22
Oman to fast-track approval of Indian pharma products registered by USFDA, UKMHRA, EMA The Times of India16:57 11-May-22
Extended mandate: First meeting of Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) European Medicines Agency16:32 11-May-22
Instem Awarded EMA Research Grant Business Wire (Press Release)13:02 10-May-22
Positive scientific opinion from EMA on human insulin with more flexible storage without… The Daily Star, Bangladesh20:08 7-May-22
EU could approve vaccines adapted to target COVID-19 variants by September People's Daily04:01 6-May-22
EU regulator aims to approve vaccines adapted to new COVID-19 variants by September Anadolu Agency16:09 5-May-22
EMA says it hopes to approve Covid variant-adapted vaccines by autumn Reuters14:37 5-May-22
EMA business hours on Europe Day, Monday 9 May European Medicines Agency13:58 5-May-22
EMA starts review of cancer medicine Rubraca European Medicines Agency08:48 4-May-22
Instem secures European Medicines Agency research grant London South East13:01 3-May-22
Byondis and medac Enter Into License and Collaboration and Supply Agreements for Anti-HER2 ADC… PR Newswire (Press Release)11:52 3-May-22
Instem research consortium lands €2.5mln European Medicines Agency grant Proactive Investors (UK)07:50 3-May-22
uniQure Announces First Quarter 2022 Financial Results and Highlights Recent Company Progress GlobeNewswire (Press Release)12:07 2-May-22
Moderna Files With EU to Expand CMA for Covid-19 Vaccine MarketWatch17:05 29-Apr-22
Moderna Files to Expand Conditional Marketing Authorization for Its COVID-19 Vaccine to Include … DGAP16:36 29-Apr-22
EMA’s human medicines committee (CHMP) April 2022 meeting highlights European Pharmaceutical Review09:53 29-Apr-22
Janssen Submits Marketing Authorisation Application to EMA Seeking Approval of Niraparib and… Business Wire (Press Release)13:54 28-Apr-22
Valneva’s Covid-19 vaccine hits another bump with EMA request for further data Pharmaceutical Technology18:25 27-Apr-22
Neoadjuvant Pembrolizumab/Chemo Followed by Adjuvant Pembrolizumab Approaches EU Approval for High-Risk, Early-Stage… OncLive02:53 27-Apr-22
EMA delays Valneva vaccine approval European Biotechnology News13:52 26-Apr-22
Valneva slumps after EU regulator requests more COVID vaccine data, article with image Reuters15:46 25-Apr-22
Amryt Earns Wings For Butterfly Skin Drug In Europe Scrip Pharma Intelligence14:41 25-Apr-22
Valneva says the EMA wants additional data about its experimental COVID-19 shot MarketWatch13:49 25-Apr-22
EMA business hours over King's Day holiday European Medicines Agency11:03 25-Apr-22
EMA CHMP recommends Novartis’ Tabrecta for non-small cell lung cancer Pharmaceutical Technology10:59 25-Apr-22
Valneva Shares Fall After EMA Requested More Data on Covid-19 Vaccine MarketWatch09:06 25-Apr-22
EU drug Regulator asks Valneva for more info on Covid vaccine candidate Yahoo! UK & Ireland06:16 25-Apr-22
ObsEva Announces Confirmation of Positive CHMP Opinion for Linzagolix, an Oral GnRH Antagonist, for the Treatment of… GlobeNewswire (Press Release)06:01 25-Apr-22
Valneva Provides Regulatory Update on its inactivated COVID-19 Vaccine Candidate GlobeNewswire (Press Release)06:01 25-Apr-22
Adjuvant Atezolizumab Approaches EU Approval for High-Risk NSCLC With PD-L1 of ≥50% OncLive22:38 22-Apr-22
EMA recommends authorisation of Amryt's EB treatment RTE17:51 22-Apr-22
Commission confirms support for EMA’s advice on antimicrobials for humans only EurActiv.com16:21 22-Apr-22
Biogen Pulls European Application for Approval of Alzheimer's Drug Aduhelm MarketWatch16:07 22-Apr-22
Amryt Pharma Shares Rise 5% After Positive CHMP Opinion for Filsuvez MarketWatch15:37 22-Apr-22
EU regulator backs using Pfizer COVID shot as booster after other vaccines, article with image Reuters14:58 22-Apr-22
Update on Regulatory Submission for Aducanumab in the European Union Biogen (Press Release)14:15 22-Apr-22
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20 May 19:57

EMA News

NewsNow brings you the latest news from the world’s most trusted sources on European Medicines Agency. NewsNow aims to be the world’s most accurate and comprehensive EMA news aggregator, bringing you the latest headlines automatically and continuously 24/7. N.B. Relevance is automatically assessed so some headlines not qualifying as European Medicines Agency news might appear - please feel free to contact us regarding any persistent issues.
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World Top Stories

Concern mounts over fate of 2,500 Ukrainian POWs from Mariupol steel plant LBC News08:27Mariupol Ukraine Russia
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Female Afghan TV journalists appear with faces covered following Taliban order Radio Free Europe10:07US/Afghanistan Taliban Afghanistan
Afghan women TV presenters forced to cover their faces The New Arab10:48US/Afghanistan Taliban Afghanistan
Anthony Albanese: Who is Australia's new PM and what does he stand for? ITV08:55Anthony Albanese Australian Politics Australia
Australia's Labor to retake power after 9 years, independents may hold sway The Peninsula06:19Anthony Albanese Australian Politics Australia
Biden extends 'Hello' to Kim Jong Un amid nuclear tensions Deutsche Welle10:55US/North Korea North Korea Joe Biden
Biden greets Kim, but says US ‘prepared’ for North Korea weapons test Malay Mail08:56US/North Korea North Korea Joe Biden
'No positive approach for Sweden, Finland's NATO bids unless they show solidarity with Turkey' Yeni Şafak07:35Sweden/Turkey NATO Turkey
Erdogan Speaks to Stoltenberg over Finland, Sweden NATO Bid Fars News Agency08:37Sweden/Turkey NATO Turkey

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