EU
Sharp invests $100m in US and EU manufacturing and packaging facilities
October 27, 2025Manufacturing and Production EU, Sharp Services, US, manufacturing and packaging
Sharp Services, a pharmaceutical packaging and sterile manufacturing specialist, has announced investments totalling $100m across its US and European facility …
Sarclisa recommended for EU approval in newly diagnosed multiple myeloma
June 24, 2025Research and Development Committee for Medicinal Products for Human USE, EU, European Commission, European Medicines Agency, German-speaking Myeloma Multicenter Group, Oncology, Sanofi, blood cancer, monoclonal antibody
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi’s Sarclisa (isatuximab) for approval in …
EU approval granted for rare kidney disease treatment
April 29, 2025Market Access, Research and Development, Sales and Marketing CSL Vifor, EU, Nephrology, Travere Therapeutics, kidney disease, nephrology
The EU has granted marketing authorisation (MA) for Filspari – CSL Vifor and Travere Therapeutics’ therapy for primary IgA nephropathy …
Inbiome’s rapid diagnostic platform approved for EU use, cuts infection identification time to just five hours
April 11, 2025Research and Development Diagnostics, EU, Inbiome
Dutch diagnostics firm Inbiome has received In Vitro Diagnostic Regulation (IVDR) certification from the EU for its Molecular Culture ID …
Spinal cord stimulator with AI technology receives CE Mark certification
November 13, 2024Research and Development AI, EU, Nevro, Pain, spinal cord stimulation
The HFC iQ, a personalised spinal cord stimulation (SCS) system developed by Nevro that leverages AI technology to manage chronic …
Eplontersen recommended for EU approval by CHMP for treatment of hereditary transthyretin-mediated amyloidosis
October 21, 2024Research and Development CHMP, EMA, EU, Internal Medicine, gene
Wainzua (eplotersen), produced by AstraZeneca and Ionis, has been recommended for approval in the European Union (EU) by the European …
CytoSorbents announces EU launch and availability of PuriFi blood pump
June 14, 2024Medical Communications CytoSorbents, EU, Haematology, PuriFi, blood pump
CytoSorbents Corporation has announced the launch and immediate availability of its PuriFi haemoperfusion machine in the EU following its approval …
GSK’s Jemperli approved in EU as treatment for endometrial cancer
December 11, 2023Medical Communications EU, GSK, Jemperli, Oncology, endometrial cancer
GSK has announced that the European Commission (EC) has granted marketing authorisation to Jemperli (dostarlimab) in combination with carboplatin-paclitaxel chemotherapy, …
Daiichi Sankyo’s Vanflyta approved by EC for acute myeloid leukaemia treatment
November 10, 2023Medical Communications Daiichi Sankyo, EC, EU, Oncology, Vanflyta, acute myeloid leukaemia
Daiichi Sankyo has announced that Vanflyta (quizartinib) has been approved in the EU for combination use with standard cytarabine and …
GSK’s RSV vaccine approved in EU for older adults
June 7, 2023Medical Communications EU, GSK, Infections and infestations, RSV, Vaccine
GSK has announced that the European Commission (EC) has authorised Arexvy, the company’s respiratory syncytial virus (RSV) vaccine for active …
European Parliament shares goal to tackle antimicrobial resistance
June 2, 2023Medical Communications EU, European Parliament, Microbiology, antimicrobial resistance
The European Parliament has shared its recommendations for a “coordinated EU response to health threats posed by antimicrobial resistance,” according …
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) …
EMA validates HUTCHMED MAA for neuroendocrine tumour drug
July 16, 2021Medical Communications EU, oncology
China-based biotech HUTCHMED has announced that the EMA has validated and accepted the Marketing Authorisation Application (MAA) for surufatinib, for …
Visitors with non-EU approved jabs allowed in Madeira
July 5, 2021Sales and Marketing COVID-19, EU, Vaccine, travel
Popular holiday destination, the Portuguese islands of Madeira, have announced that they will allow visitors with any COVID-19 vaccine, even …
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 …
