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EMA

Showing 15 posts of 400 posts found.

Regeneronโ€™s linvoseltamab gains EMA filing acceptance for R/R MM treatment

February 5, 2024
Medical Communications EMA, Oncology, Regeneron, linvoseltamab, multiple myeloma

Regeneron Pharmaceuticals has announced that the European Medicines Agency (EMA) has accepted for review its Marketing Authorisation Application (MAA) for …

News

EMA to review GSKโ€™s Arexvy for RSV prevention in adults aged 50-59

January 29, 2024
Medical Communications Arexvy, EMA, Infections and infestations, RSV

GSK has announced that the European Medicines Agency (EMA) has accepted the companyโ€™s regulatory application to expand the use of …

News

BridgeBio Pharma shares positive feedback from FDA and EMA for phase 3 trial of infigratinib

September 7, 2023
Research and Development BridgeBio Pharma, EMA, FDA, Musculo-skeletal disorder, achondroplasia, clinical trial

BridgeBio Pharma has announced positive feedback from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on …

News

Iveric Bioโ€™s marketing authorisation application for avacincaptad pegol accepted by EMA

August 18, 2023
Medical Communications CHMP, EMA, Iveric Bio, MAA, Opthalmology

Astellas Pharma has announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for avacincaptad pegol …

News
Vaccine image

ViiV Healthcare gains positive CHMP opinion for cabotegravir for HIV prevention

July 24, 2023
Medical Communications CHMP, EMA, HIV, HIV/AIDS, ViiV Healthcare, cabotegravir

GSK has announced that ViiV Healthcare has received a positive opinion from the European Medicines Agencyโ€™s (EMA) Committee for Medicinal …

News
Chemotherapy

EMA accepts Astellasโ€™ MAA for Zolbetuximab

July 14, 2023
Medical Communications Astellas, Cancer, EMA, Oncology, zolbetuximab

Astellas Pharma has announced that the European Medicines Agency (EMA) has accepted the companyโ€™s marketing authorisation application (MAA) for regulatory …

News

OSE Immunotherapiesโ€™ UC drug gets DSMB positive recommendation

July 6, 2023
Research and Development EMA, Gastrointestinal tract, OSE Immunotherapeutics, ulcerative colitis

Frenchย biotech company OSE Immunotherapeutics has announced that its Ulcerative Colitis (UC) trialโ€™s Independent Drug Safety Monitoring Board (DSMB) has provided …

News

AstraZenecaโ€™s Soliris given EU CHMP recommendation for marketing authorisation

June 26, 2023
Medical Communications AstraZeneca, CHMP, EMA, Immunology, soliris

UK-based biopharmaceutical company AstraZeneca has announced that the European Medicines Agencyโ€™s (EMAโ€™s) Committee for Medicinal Products for Human Use (CHMP) …

News

CHMP gives positive opinion recommending authorisation to GSKโ€™s CKD drug

June 26, 2023
Medical Communications CKD, EMA, Nephrology

Global biopharmaceutical company GSK has announced that the European Medicines Agencyโ€™s (EMAโ€™s) Committee for Medicinal Products for Human Use (CHMP) …

News

Is the pharmaceutical sector prepared to face a titanium dioxide ban?

May 19, 2023
Manufacturing and Production ACG, EMA, EU, Titanium Dioxide

Dr Subhashis Chakraborty, head of Global Product Management, ACG Capsules In the wake of the ban on titanium dioxide (TiO2) …

News
Press release

Spanner in the works for Sputnik V as missing data reported

July 13, 2021
Manufacturing and Production COVID-19, EMA, Russia, Vaccine

Developers of Russiaโ€™s Sputnik V COVID-19 vaccine have repeatedly failed to present data to regulators, Reuters has reported. Five sources …

News
stock-incyte-01-shutter

CHMP issue positive opinion for Incyte and MorphoSysโ€™ tafasitamab

June 29, 2021
Manufacturing and Production CHMP, EMA, EU, FDA, US

Incyte and MorphoSys have announced that the EMAโ€™s Committee for Medicinal Products for Human Use (CHMP) has issued a positive …

News
biogen_austria_238

Samsung Bioepis & Biogen receive positive CHMP opinion for ranibizumab biosimilar

June 28, 2021
Sales and Marketing EC, EMA, EU, biosimilars

Samsung Bioepis and Biogen have announced that the EMAโ€™s Committee for Medicinal Products for Human Use (CHMP) has adopted a …

News
credit_-_daniel_leal-olivas-afp

Kiteโ€™s leukaemia cell therapy application validated by EMA

June 24, 2021
EMA, Kite, leukemia

Kite has announced that their Type II variation application for a new indication to the approved license for autologous anti-CD19-transduced …

News

FDA accepts Ipsenโ€™s NDA for ultra-rare genetic disorder drug

June 1, 2021
Manufacturing and Production EMA, FDA, FOP, NDA, ipsen

The FDA have accepted Ipsenโ€™s New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARฮณ agonist for the prevention …

News
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AstronauTx appoints Adam Rosenberg as Chair of the Board

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Astellas Pharmaโ€™s Vyloy accepted by Scottish Medicines Consortium for gastric cancer

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QV Bioelectronics secures ยฃ4.5m in funding for brain cancer therapy development

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