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EU

Showing 15 posts of 252 posts found.

Sharp invests $100m in US and EU manufacturing and packaging facilities

October 27, 2025
Manufacturing 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 …

News

Sarclisa recommended for EU approval in newly diagnosed multiple myeloma

June 24, 2025
Research 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 …

News
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EU approval granted for rare kidney disease treatment

April 29, 2025
Market 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 …

News

Inbiome’s rapid diagnostic platform approved for EU use, cuts infection identification time to just five hours

April 11, 2025
Research 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 …

News

Spinal cord stimulator with AI technology receives CE Mark certification

November 13, 2024
Research 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 …

News

Eplontersen recommended for EU approval by CHMP for treatment of hereditary transthyretin-mediated amyloidosis

October 21, 2024
Research 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 …

News

CytoSorbents announces EU launch and availability of PuriFi blood pump

June 14, 2024
Medical 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 …

News

GSK’s Jemperli approved in EU as treatment for endometrial cancer

December 11, 2023
Medical 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, …

News

Daiichi Sankyo’s Vanflyta approved by EC for acute myeloid leukaemia treatment

November 10, 2023
Medical 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 …

News
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GSK’s RSV vaccine approved in EU for older adults

June 7, 2023
Medical 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 …

News
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European Parliament shares goal to tackle antimicrobial resistance

June 2, 2023
Medical 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 …

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

EMA validates HUTCHMED MAA for neuroendocrine tumour drug

July 16, 2021
Medical Communications EU, oncology

China-based biotech HUTCHMED has announced that the EMA has validated and accepted the Marketing Authorisation Application (MAA) for surufatinib, for …

News

Visitors with non-EU approved jabs allowed in Madeira

July 5, 2021
Sales 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 …

News
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CHMP issue positive opinion for Incyte and MorphoSys’ tafasitamab

June 29, 2021
Manufacturing 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 …

News
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STADA and Bio-Thera’s Gotenfia receives positive CHMP opinion for autoimmune diseases

December 18, 2025

Norgine enters exclusive licensing agreement with Vir Biotechnology

December 18, 2025

Incyclix appoints Kimberly Blackwell to Board of Directors

December 17, 2025

Hansa Biopharma appoints Max Sakajja as Vice President, General Manager Europe and International

December 17, 2025

GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis

December 16, 2025