GSK’s Arexvy Is First RSV Vaccine Approved By FDA, But A Second Is Poised To Follow

Arexvy will launch in the US in time for the fall 2023 RSV season for adults 60 and older, GSK said. Pfizer’s Abrysvo is also pending at the FDA.

GSK got its RSV vaccine across the FDA finish line first • Source: Shutterstock

GSK plc’s Arexvy is the first vaccine approved for respiratory syncytial virus (RSV) by the US Food and Drug Administration. The approval is an accomplishment, but the vaccine is likely to face a challenge in the commercial market from the coinciding launch of a timely rival.

Pfizer Inc

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

Pipeline Watch: Eight Approvals And Nineteen Phase III Readouts

19 May 2025

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

In Brief: US FDA Delay Sends Biohaven Shares Down

16 May 2025

• By Andrew McConaghie

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

Strong Showing For Bayer’s Pharma Business In Uncertain Times

13 May 2025

• By Kevin Grogan

As CEO Anderson backs high prices for innovative drugs in Europe

Biopharma Deals ROI Has Fallen And Market Instability Could Make It Worse

12 May 2025

• By Andrew McConaghie

Rising biotech valuations mean return on investment on some deals is non-existent for big pharma, though certain strategies will improve chances of success, a new analysis has found.

First Blood-Based Test Cleared For Alzheimer’s Boosts Anti-Amyloid Drugs

19 May 2025

• By Mandy Jackson

The US FDA approval of Fujirebio’s Lumipulse should boost access to medicines like Eisai’s Leqembi and Lilly’s Kisunla; the firms are praising patients’ access to earlier diagnoses.