FDA+ channel feed – Endpoints News

FDA+ channel feed

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

7 months ago

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

7 months ago

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

7 months ago

Novo Nordisk petitions FDA to stop semaglutide compounding over safety risks

7 months ago

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

7 months ago

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

7 months ago

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

7 months ago

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

7 months ago

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

7 months ago

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

7 months ago

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

7 months ago

FDA hits Camurus with CRL for acromegaly therapy over manufacturing issues

7 months ago

Biden administration calls for expanded contraception coverage

7 months ago

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

7 months ago

Lykos is optimistic about MDMA treatment after meeting with FDA

7 months ago

FDA won't take action against GLP-1 compounders as it rethinks tirzepatide shortage

7 months ago

FDA approves Astellas' gastric cancer drug Vyloy ahead of schedule

7 months ago

EMA again recommends against authorization for PTC Therapeutics' Translarna

7 months ago

European Commission to work more closely with European Medicines Agency

7 months ago

FDA partially holds BioNTech's Phase 3 anti-CTLA-4, company pauses enrollment

7 months ago

Intercept's liver disease drug faces full approval delay following negative adcomm

7 months ago

FDA finalizes guidance on generic drugs, cancer trials and neonatal drug development

7 months ago

FDA delays colorectal cancer decision for Amgen's Lumakras, a setback in race with Bristol Myers

7 months ago

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