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

8 months ago

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

8 months ago

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

8 months ago

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

8 months ago

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

8 months ago

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

8 months ago

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

8 months ago

FDA hits Camurus with CRL for acromegaly therapy over manufacturing issues

8 months ago

Biden administration calls for expanded contraception coverage

8 months ago

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

8 months ago

Lykos is optimistic about MDMA treatment after meeting with FDA

8 months ago

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

8 months ago

FDA approves Astellas' gastric cancer drug Vyloy ahead of schedule

8 months ago

EMA again recommends against authorization for PTC Therapeutics' Translarna

8 months ago

European Commission to work more closely with European Medicines Agency

8 months ago

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

8 months ago

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

8 months ago

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

FDA expands label for Avadel's narcolepsy drug into children

8 months ago

FDA approves AbbVie's 24-hour Parkinson's infusion therapy after two CRLs

8 months ago

Compounding association to ask for clarity around tirzepatide's shortage status

8 months ago

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

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