FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA advisors question whether Iterum's application for a UTI antibacterial is restrictive enough

8 months ago

CDER chief on inspection backlog: 2025 will be a 'crucial year'

8 months ago

FDA grants full approval to Travere’s Filspari for IgAN

8 months ago

Milestone’s arrhythmia drug on track for China filing with new Phase 3 data

8 months ago

FDA raises antimicrobial resistance concerns ahead of adcomm for Iterum's UTI treatment

8 months ago

CBER chief forecasts better global regulatory convergence around cell and gene therapies

8 months ago

European Commission revokes Ocaliva's authorization ahead of FDA adcomm

8 months ago

FDA authorizes Novavax's updated Covid booster

8 months ago

Biosecure vote slated for September

8 months ago

Ipsen sells priority review voucher for highest price since 2016

8 months ago

FDA approves Emergent vaccine for mpox as company plans to donate 50,000 doses

8 months ago

FDA’s drug evaluation wing launches new AI oversight panel

8 months ago

Pennsylvania judge sides with drugmakers on first steps for growing GLP-1 lawsuits

8 months ago

FDA hints at what Chevron's elimination means in new SCOTUS filing

8 months ago

House Oversight chair tells PBM CEOs to correct testimonies from July hearing

9 months ago

FDA warns EyePoint over eye implant manufacturing woes

9 months ago

Biopharma companies, BARDA call for more clarity on FDA's new platform tech proposal

9 months ago

Illumina wins FDA approval for test to identify treatable cancers

9 months ago

Federal agency opposes J&J's new 340B discount model, promises to take 'actions as warranted'

9 months ago

Regeneron wins EU approval for lymphoma bispecific following FDA rejection

9 months ago

CDER chief says 'standards have not changed,' explaining increase in CRLs for biologics

9 months ago

FDA to host adcomm on PD-L1 as a predictive biomarker for checkpoint inhibitors

9 months ago

FDA approves reformulated Covid boosters for fall season

9 months ago

FDA closes the door on Intarcia's eight-year bid for diabetes drug-device combo

9 months ago

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