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Future of MHRA uncertain amid Brexit-fuelled shake up

Trade unions and regulatory experts warn that budget and staff cuts may lead to drug approval delays or the UK regulator simply rubber-stamping EMA decisions

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CureVac to push ahead with first- and second-generation COVID-19 vaccines

The biotech will seek EMA approval for first-generation jab while trials are due to start for second-generation jabs in Q4

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EMA to evaluate Roche arthritis drug RoActemra for severe COVID-19

FDA approval has already been granted following positive phase 3 trials

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CHMP rejects Kyowa Kirin’s Parkinson’s disease drug

Results of eight main studies of drug were 'inconsistent', according to the CHMP

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EMA authorises Pfizer/BioNTech’s COVID-19 vaccine for children aged 12 to 15

Clinical trial data recently showed that the vaccine is safe and effective in individuals in this age group

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bluebird bio’s CALD gene therapy Skysona gains positive opinion from CHMP

CHMP's marketing authorisation recommendation is a step towards gaining EU approval

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J&J’s multiple sclerosis therapy Ponvory moves closer to EU approval

CHMP issues a positive opinion for S1P1 modulator based on positive phase 3 results

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EMA begins accelerated review of Gilead’s Trodelvy for triple-negative breast cancer

FDA approved the antibody-drug conjugate in this indication in April 2020

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J&J’s one-dose COVID-19 vaccine granted EU authorisation

Company aiming to begin vaccine delivery to EU in the second half of April

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EMA starts rolling review of Lilly’s COVID-19 antibodies

CHMP will review the combination of bamlanivimab and etesemivab as well as bamlanivimab monotherapy

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EMA recommends use of Lilly’s COVID-19 antibody cocktail

Agency concludes bamlanivimab and etesevimab can be used to treat certain COVID-19 patients

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EMA begins rolling review process for Sputnik V COVID-19 vaccine

Late-stage trial results found vaccine gives 91.6% protection against COVID-19

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