FDA+ channel feed – Endpoints News

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Following 2019 rejection, FDA adcomm votes against Lexicon's type 1 diabetes and CKD drug

6 months ago

Federal court backs FDA's approval of competitor to Jazz's sleep drug

6 months ago

FDA says all versions of Novo's GLP-1 weight loss drugs are now available

6 months ago

Following March inspection, Novo Nordisk's semaglutide manufacturing facility cited by FDA

6 months ago

Biopharma begins to contemplate an RFK Jr.-influenced FDA if Trump wins

6 months ago

Lexicon's once-rejected diabetes drug is questioned again by FDA ahead of adcomm

6 months ago

Novartis expands Scemblix label to first-line CML patients

6 months ago

#HLTH24: GLP-1 compounding pharmacies took center stage at digital health’s biggest conference

6 months ago

Bipartisan letter questions FDA's 'narrow' interpretation for priority review vouchers

6 months ago

House Republicans push for more transparency on government-funded trial data

6 months ago

Iterum wins approval for new oral antibiotic for UTIs. Now it wants a partner

6 months ago

CDC advisors decline to recommend RSV shots to younger at-risk adults, affirming prior guidance

6 months ago

Novo Nordisk petitions FDA to stop semaglutide compounding over safety risks

6 months ago

GSK offers glimpse at RSV vaccine in at-risk younger adults before ACIP meeting

6 months ago

Adults 50 and up should get pneumococcal vaccine, CDC advisors say, in boost to Pfizer and Merck

6 months ago

Pfizer wins approval to expand RSV vaccine to adults at higher infection risk

6 months ago

Novo Nordisk asks FDA to prohibit semaglutide compounding, following Eli Lilly

6 months ago

Corrected: Sangamo to seek accelerated approval for Fabry gene therapy, claims it won't need confirmatory study

6 months ago

Lawyers predict Biosecure passage in lame duck session, but Senate may decide key details

6 months ago

ICER slightly softens its recommendation on Pfizer's ATTR-CM drug price

6 months ago

FDA hits Camurus with CRL for acromegaly therapy over manufacturing issues

6 months ago

Biden administration calls for expanded contraception coverage

6 months ago

FDA to launch pilot project for more transparency on generic drug delays

6 months ago

Lykos is optimistic about MDMA treatment after meeting with FDA

7 months ago

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