Roche receives positive CHMP opinion for Evrysdi, the first and only at home spinal muscular atrophy treatment with proven efficacy in adults, children and infants two months and older

26 February 2021 - Evrysdi is approved in seven countries, submitted in 30 more. ...

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BioCryst receives positive CHMP opinion for Orladeyo (berotralstat), an oral, once daily therapy to prevent attacks in patients with hereditary angioedema

25 February 2021 - BioCryst Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion recommending ...

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Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers

25 February 2021 - EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in ...

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International cooperation to align approaches for regulation of COVID-19 vaccines and medicines

25 February 2021 - Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate ...

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EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19

24 February 2021 - EMA’s CHMP has started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (also known ...

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EMA publishes agenda for 22-25 February CHMP meeting

22 February 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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EMA plots earlier engagement with patient groups

19 February 2021 - The EMA on Friday announced it will pilot an early engagement program to bring patient and ...

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von der Leyen admits to COVID-19 vaccine failures

20 February 2021 - EU Commission President Ursula von der Leyen's comments come after much scrutiny of the EU vaccination ...

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Dynavax announces European Commission marketing authorization for Heplisav B, a two dose adult hepatitis B adjuvanted vaccine

19 February 2021 - Approval based on safety and immunogenicity results from three Phase 3 clinical trials. ...

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Confusion over Russia's EU vaccine approval bid could be result of misdirected application

20 February 2021 - Russia’s submission of its Sputnik V vaccine for approval by the European Union’s medicines regulator appears ...

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Pfizer and BioNTech to supply the European Union with 200 million additional doses of Cominarty

17 February 2021 - New agreement brings total supply to the European Union to 500 million doses, with delivery expected by ...

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EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen

16 February 2021 - EMA has received an application for conditional marketing authorisation for a COVID-19 vaccine developed by Janssen-Cilag. ...

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Celltrion Healthcare receives European Commission approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab, Yuflyma (CT-P17)

15 February 2021 - Yuflyma is approved in all intended indications for the treatment of multiple chronic inflammatory diseases. ...

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Xeris Pharmaceuticals receives European Commission approval of Ogluo (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus

12 February 2021 - Ogluo Europe’s first and only ready-to-use liquid glucagon for rescue. ...

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European Commission approves Seagen’s Tukysa (tucatinib) for the treatment of patients with locally advanced or metastatic HER2 positive breast cancer

12 February 2021 - Approved for adult patients with HER2 positive metastatic breast cancer who have received at least two prior ...

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