EU

Showing 15 posts of 245 posts found.

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, …

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 …

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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 …

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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 …

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) …

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 …

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 …

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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 …

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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 EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a …

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Sanofi’s NSCLC drug gains EC approval

June 25, 2021
Medical Communications EC, EU, NSCLC, Sanofi

The European Commission (EC) has approved Sanofi and Regeneron’s PD-1 inhibitor, Libtayo (cemiplimab), for the first-line treatment of adults with …

Exscientia buys Austrian cancer cell screening company for €50 million

June 17, 2021
AI, EU, deal, marketing, sales

UK-based AI pioneers Exscientia has announced the purchase of rival AI firm Allcyte for €50 million. The multimillion deal, paid …

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MHRA approves venetoclax as acute myeloid leukemia treatment

June 8, 2021
Manufacturing and Production EC, EU, MHRA, leukemia

The MHRA has announced its approval for AbbVie’s venetoclax, in combination with a hypomethylating agent, for the treatment of newly …

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MHRA confirms registration of Avacta’s lateral flow test

June 7, 2021
Sales and Marketing COVID-19, EU, MHRA, lateral flow test

Avacta has announced that the MHRA has confirmed registration of the AffiDX SARS-CoV-2 antigen lateral flow test, which allows the …

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Moderna submits BLA with FDA for COVID vaccine

June 2, 2021
Research and Development COVID-19, EU, FDA, Lonza, Moderna, production

Moderna has initiated the rolling submission process with the FDA for a Biologics License Application (BLA) for the licensure of …

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AstraZeneca’s lung cancer drug gains EU approval

May 28, 2021
Medical Communications AstraZeneca, EU, lung cancer, oncology

AstraZeneca’s Tagrisso (osimertinib) has been approved in the EU for the adjuvant treatment of adult patients with early-stage (IB, II …

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