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- PMLiVE

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- PMLiVE

Keytruda combo outshines Opdivo in kidney cancer

BMS also on the backfoot after Nektar data release

Roche Basel Switzerland

Roche submits Kadcyla for FDA Real-Time review

Aims to extend use in breast cancer patients

- PMLiVE

Analysts look beyond Keytruda in Merck’s future

CEO Frazier made to defend pipeline prospects

- PMLiVE

Immunomedics craters after FDA rejects breast cancer ADC

Regulator wants to see more data on manufacturing

Sanofi reception

FDA adcomm split on Sanofi’s type 1 diabetes drug

Concerns rose after Zynquista-treated patients showed an eight-fold increase in DKA

- PMLiVE

Evenity back on track with FDA panel blessing in osteoporosis

US drugs regulator first rejected the drug due to cardiovascular concerns

- PMLiVE

FDA expecting boom in cell and gene therapies

Pledges clampdown on developers working outside regulations

- PMLiVE

FDA moves into crisis mode as shutdown drags on

New drug appraisals already being affected

- PMLiVE

US government shutdown leaves FDA running on empty

Funding row means shutdown could break 21 day record

- PMLiVE

Merck’s backing of NGM Bio yields NASH drug deal

Drug has potential in diabetes treatment as well

- PMLiVE

Merck exec steps down, two takes his place

Head of global human health Adam Schechter will transition to CEO advisor

- PMLiVE

FDA takes aim at pharma’s biosimilar-delaying tactics

Ever-rising cost of insulins also to be targeted

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