regulatory approval

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J&J's Balversa is first pan-FGFR bladder cancer drug in EU

Johnson & Johnson's Balversa has become the first drug approved in the EU to treat adults with advanced urothelial carcinoma (mUC) with FGFR3 genetic alterations after one line of prior

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New COVID-19 jabs approved by FDA for 2024-25 season

The FDA has approved new versions of Pfizer/BioNTech's Comirnaty and Moderna's Spikevax COVID-19 vaccines that target the Omicron KP.2 strain of SARS-CoV-2 which was dominant in the US in r

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US insomniacs have a new prescription DTx option

It is estimated that around one in four US adults suffer from insomnia, raising their risk of other health conditions, and the recent approval of a digital therapeutic gives them a treatmen

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J&J's Rybrevant okay challenges Tagrisso in first-line NSCLC

AstraZeneca's EGFR inhibitor Tagrisso has become the go-to therapy for EGFR-mutated non-small cell lung cancer (NSCLC), but now has competition from Johnson & Johnson's Rybrevant and La

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With FDA okay, AZ takes on MSD in early-stage lung cancer

AstraZeneca has claimed FDA approval for its immunotherapy Imfinzi before and after surgery for non-small cell lung cancer, setting up a contest with MSD's rival Keytruda.

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PBC drug choices rise in US with OK for Gilead's seladelpar

At the start of the year, there had been no new therapies for rare cholestatic liver disease primary biliary cholangitis (PBC) in the US for almost a decade.

J&J's Balversa is first pan-FGFR bladder cancer drug in EU

New COVID-19 jabs approved by FDA for 2024-25 season

US insomniacs have a new prescription DTx option

J&J's Rybrevant okay challenges Tagrisso in first-line NSCLC

With FDA okay, AZ takes on MSD in early-stage lung cancer

PBC drug choices rise in US with OK for Gilead's seladelpar

GBL joins CVC in €10.7bn takeover bid for Recordati

Discover a new era of healthcare panel engagement: Grounded ...

regulatory approval

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