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situximab

- PMLiVE

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

Committee reiterated previous negative opinion

- PMLiVE

Merck strengthens oncology pipeline with $2.75bn VelosBio deal

The deal will give Merck control of VLS-101, an antibody-drug conjugate

- PMLiVE

Novartis scores CHMP backing for cholesterol drug Leqvio

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

- PMLiVE

Pfizer and BioNTech’s COVID-19 vaccine begins EMA evaluation

Vaccine is the second to undergo EMA's 'rolling review' process after AstraZeneca/Oxford Uni's candidate

- PMLiVE

EMA begins rolling review of AZ’s COVID-19 vaccine candidate

Agency has started evaluating data from non-clinical laboratory studies

- PMLiVE

EMA accepts application for bluebird bio’s Lenti-D in CALD

Gene therapy could become a potentially transformative treatment for cerebral adrenoleukodystrophy

- PMLiVE

Janssen’s EGFR-targeting treatment regimen shows early benefit in lung cancer

Positive interim results presented at 2020 ESMO virtual congress

- PMLiVE

Janssen scores another expansion for new Darzalex combination in the US

Myeloma med approved in combination with Amgen's Kyprolis

- PMLiVE

GSK’s anti-BCMA drug leads crowded CHMP recommendations

Ten new drugs receive positive recommendations for approval

- PMLiVE

EMA to support real-world monitoring of COVID-19 treatments/vaccines

New infrastructure will support real-world studies

- PMLiVE

Merck, Bayer get FDA priority review for heart failure drug

Target action date set for January 2021

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