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- PMLiVE

regulatory decisions

- PMLiVE

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

- PMLiVE

EMA updates product information for AZ COVID-19 vaccine

PRAC reaffirms opinion that AZ vaccine's efficacy outweighs very rare likelihood of developing a blood clotting disorder

- PMLiVE

EMA review confirms AZ/Oxford’s COVID-19 vaccine is safe and effective

EU regulator said that the vaccine is not associated with an increase in the overall risk of blood clots

- PMLiVE

Benefits of AZ COVID-19 vaccine ‘continue’ to outweigh risks, says EMA’s executive director

EU regulator is expected to publish findings from its investigation on Thursday

- PMLiVE

EMA says there is ‘no indication’ AZ/Oxford’s COVID-19 vaccine causes blood clots

Agency’s safety committee added vaccine’s benefits continue to outweigh risks

- PMLiVE

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

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

- PMLiVE

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

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

- PMLiVE

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

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

- PMLiVE

J&J applies for EU authorisation for one-dose COVID-19 vaccine

Submission is based on top-line efficacy and safety data from the phase 3 ENSEMBLE trial

- PMLiVE

EU to begin new study programme investigating COVID-19 variants

Programme is expected to launch on Wednesday

regeneron headquarters

EMA launches rolling review of Regeneron’s COVID-19 antibody cocktail

Study suggests REGN-COV2 can reduce viral load in non-hospitalised patients with COVID-19

- PMLiVE

CHMP recommends EU approval for Amarin’s cardiovascular risk reduction drug

The drug is recommended for use in adult patients who are already receiving statin treatment

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