regulatory approval

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After FDA no, Regeneron gets yes from EU on odronextamab

Regeneron's CD20xCD3 bispecific antibody for non-Hodgin lymphoma (NHL) has been approved in Europe, five months after it was turned down by the FDA in the US.

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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.

After FDA no, Regeneron gets yes from EU on odronextamab

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

CDC panel votes to scrap hepatitis B birth dose advice

How to meet your physicians where they are online

regulatory approval

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