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- PMLiVE

Valchlor

- 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

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

Roche Basel Switzerland

Roche’s flu pill Xofluza moves closer towards EU approval

CHMP recommends drug for approval in the EU

- PMLiVE

Sobi’s Gamifant receives final rejection from CHMP for primary HLH

Committee reiterated previous negative opinion

- PMLiVE

Novartis scores CHMP backing for cholesterol drug Leqvio

Potential first-in-class treatment moves closer to EU approval

- PMLiVE

FDA sets January decision date for Xalkori in ALK-positive lymphoma

FDA submission is based on results from ADVL0912 and A8081013 studies

- PMLiVE

NICE recommends Roche’s Polivy for B-cell lymphoma

Cost-effectiveness agency approves drug following initial rejection earlier this year

- PMLiVE

GSK’s anti-BCMA drug leads crowded CHMP recommendations

Ten new drugs receive positive recommendations for approval

- PMLiVE

In virtual meeting, CHMP backs Sanofi’s myeloma drug Sarclisa

Monthly meeting held remotely for the first time due to COVID-19 pandemic

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