EMA
AstraZeneca’s Voydeya recommended for approval in EU by CHMP
February 29, 2024Medical Communications AstraZeneca, CHMP, EMA, Haematology, Voydeya
AstraZeneca has announced that Voydeya (danicopan) has been recommended for marketing authorisation in the European Union (EU) by the Committee …
Regeneron’s linvoseltamab gains EMA filing acceptance for R/R MM treatment
February 5, 2024Medical 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 …
EMA to review GSK’s Arexvy for RSV prevention in adults aged 50-59
January 29, 2024Medical Communications Arexvy, EMA, Infections and infestations, RSV
GSK has announced that the European Medicines Agency (EMA) has accepted the company’s regulatory application to expand the use of …
BridgeBio Pharma shares positive feedback from FDA and EMA for phase 3 trial of infigratinib
September 7, 2023Research 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 …
Iveric Bio’s marketing authorisation application for avacincaptad pegol accepted by EMA
August 18, 2023Medical 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 …
ViiV Healthcare gains positive CHMP opinion for cabotegravir for HIV prevention
July 24, 2023Medical Communications CHMP, EMA, HIV, HIV/AIDS, ViiV Healthcare, cabotegravir
GSK has announced that ViiV Healthcare has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal …
EMA accepts Astellas’ MAA for Zolbetuximab
July 14, 2023Medical Communications Astellas, Cancer, EMA, Oncology, zolbetuximab
Astellas Pharma has announced that the European Medicines Agency (EMA) has accepted the company’s marketing authorisation application (MAA) for regulatory …
OSE Immunotherapies’ UC drug gets DSMB positive recommendation
July 6, 2023Research and Development EMA, Gastrointestinal tract, OSE Immunotherapeutics, ulcerative colitis
French biotech company OSE Immunotherapeutics has announced that its Ulcerative Colitis (UC) trial’s Independent Drug Safety Monitoring Board (DSMB) has provided …
AstraZeneca’s Soliris given EU CHMP recommendation for marketing authorisation
June 26, 2023Medical Communications AstraZeneca, CHMP, EMA, Immunology, soliris
UK-based biopharmaceutical company AstraZeneca has announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) …
CHMP gives positive opinion recommending authorisation to GSK’s CKD drug
June 26, 2023Medical Communications CKD, EMA, Nephrology
Global biopharmaceutical company GSK has announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) …
Is the pharmaceutical sector prepared to face a titanium dioxide ban?
May 19, 2023Manufacturing 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) …
Spanner in the works for Sputnik V as missing data reported
July 13, 2021Manufacturing and Production COVID-19, EMA, Russia, Vaccine
Developers of Russia’s Sputnik V COVID-19 vaccine have repeatedly failed to present data to regulators, Reuters has reported. Five sources …
CHMP issue positive opinion for Incyte and MorphoSys’ tafasitamab
June 29, 2021Manufacturing and Production CHMP, EMA, EU, FDA, US
Incyte and MorphoSys have announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive …
Samsung Bioepis & Biogen receive positive CHMP opinion for ranibizumab biosimilar
June 28, 2021Sales and Marketing EC, EMA, EU, biosimilars
Samsung Bioepis and Biogen have announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a …
Kite’s leukaemia cell therapy application validated by EMA
June 24, 2021EMA, Kite, leukemia
Kite has announced that their Type II variation application for a new indication to the approved license for autologous anti-CD19-transduced …
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