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- PMLiVE

Valchlor

- 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

- PMLiVE

Modest meeting sees only two drugs recommended by CHMP

Lilly’s migraine med Emgality receives negative opinion for label extension

- PMLiVE

Givlaari, Rybelsus lead crowded CHMP recommendations

EU regulator delivered 15 positive opinions and no rejections

Bristol Myers Squibb logo

Another blow for BMS in first-line NSCLC as it pulls EU filing

Opdivo/Yervoy combination is still under review with the FDA

- PMLiVE

EU grants conditional approval to Roche’s lymphoma drug Polivy

Drug demonstrated a 40% complete response rate in trial

- PMLiVE

Incyte signs lymphoma deal worth up to $1.1bn with MorphoSys

Will pay $750m upfront for co-commercialisation rights

- PMLiVE

AstraZeneca wins FDA approval for Calquence in chronic lymphoma

Takes the fight to AbbVie and J&J's lymphoma rival Imbruvica

- PMLiVE

Novartis’ Mayzent and Roche’s Polivy lead CHMP recommendations

Sanofi Genzyme’s Lemtrada and Pfizer's Xeljanz receive label restrictions

- PMLiVE

CHMP says OK to UCB/Amgen’s Evenity for osteoporosis after appeal

Initially received a negative opinion of the drug

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