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- PMLiVE

Wilson Therapeutics

- PMLiVE

J&J’s Spravato breaks depression drought at FDA

The esketamine nasal spray is the first new-mechanism antidepressant to be licensed in decades

- PMLiVE

FDA chief Scott Gottlieb to step down

Won admiration of industry and public health experts

- PMLiVE

FDA and Flatiron extend real world evidence collaboration

Roche-owned specialists at forefront of big data analysis

- PMLiVE

Intercept NASH drug closes in on FDA approval

Although the drug failed to meet secondary endpoint

- PMLiVE

CMS proposes coverage scheme for CAR-T therapies

Proposal says it would improve access to CAR-Ts

Roche Basel Switzerland

Roche submits Kadcyla for FDA Real-Time review

Aims to extend use in breast cancer patients

- 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

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