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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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CHMP recommends eight new medicines for EU approval

BMS’ CAR T therapy Abecma and BioMarin’s dwarfism drug Voxzogo among positive recommendations

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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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Sandoz reveals antibiotic manufacturing expansion plans in Europe

Builds on company's previous commitments to drive the long-term future of integrated antibiotics manufacturing in Europe

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EMA introduces new measures to enable flexibility for non-COVID-19 procedures

Regulator will streamline processes to allow its experts to focus on COVID-19-related assessments

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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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