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FDA+ channel feed
GSK offers glimpse at RSV vaccine in at-risk younger adults before ACIP meeting
8 months ago
R&D
Adults 50 and up should get pneumococcal vaccine, CDC advisors say, in boost to Pfizer and Merck
8 months ago
Pharma
Pfizer wins approval to expand RSV vaccine to adults at higher infection risk
8 months ago
Pharma
Novo Nordisk asks FDA to prohibit semaglutide compounding, following Eli Lilly
8 months ago
Pharma
Corrected: Sangamo to seek accelerated approval for Fabry gene therapy, claims it won't need confirmatory study
8 months ago
R&D
Cell/Gene Tx
Lawyers predict Biosecure passage in lame duck session, but Senate may decide key details
8 months ago
China
Pharma
ICER slightly softens its recommendation on Pfizer's ATTR-CM drug price
8 months ago
Pharma
FDA hits Camurus with CRL for acromegaly therapy over manufacturing issues
8 months ago
Manufacturing
Biden administration calls for expanded contraception coverage
8 months ago
Pharma
FDA to launch pilot project for more transparency on generic drug delays
8 months ago
Pharma
Lykos is optimistic about MDMA treatment after meeting with FDA
8 months ago
R&D
Pharma
FDA won't take action against GLP-1 compounders as it rethinks tirzepatide shortage
8 months ago
Law
Health Tech
FDA approves Astellas' gastric cancer drug Vyloy ahead of schedule
8 months ago
Pharma
EMA again recommends against authorization for PTC Therapeutics' Translarna
8 months ago
Pharma
European Commission to work more closely with European Medicines Agency
8 months ago
Law
FDA partially holds BioNTech's Phase 3 anti-CTLA-4, company pauses enrollment
8 months ago
R&D
Pharma
Intercept's liver disease drug faces full approval delay following negative adcomm
8 months ago
Pharma
FDA finalizes guidance on generic drugs, cancer trials and neonatal drug development
8 months ago
FDA delays colorectal cancer decision for Amgen's Lumakras, a setback in race with Bristol Myers
8 months ago
Pharma
FDA expands label for Avadel's narcolepsy drug into children
8 months ago
Pharma
FDA approves AbbVie's 24-hour Parkinson's infusion therapy after two CRLs
8 months ago
Pharma
Compounding association to ask for clarity around tirzepatide's shortage status
8 months ago
Pharma
FDA leaders kick off rare disease hub to increase cross-center collaboration
8 months ago
FDA places hold on Novavax's Covid-flu and standalone influenza vaccines
8 months ago
R&D
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