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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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J&J's bid to change pay model for Stelara, Xarelto slammed

A US government agency has hit back at a plan by Johnson & Johnson to change the way it pays discounts on drugs to hospitals participating in the 340B programme for healthcare systems s

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Blood smear from a person with myelodysplastic syndrome

ICER says Geron's just-approved Rytelo is too pricey

Geron's first-in-class cancer drug Rytelo, recently approved by the FDA for myelodysplastic syndromes (MDS), is priced three to four times higher than it should be, according to the Institu

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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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UK first country in Europe to clear Leqembi, but NICE says n...

The UK drugs regulator has approved Eisai and Biogen's Alzheimer's disease therapy Leqembi, shortly after an EU committee turned it down on the grounds that its modest efficacy did not outw

After FDA no, Regeneron gets yes from EU on odronextamab

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

J&J's bid to change pay model for Stelara, Xarelto slammed

ICER says Geron's just-approved Rytelo is too pricey

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

UK first country in Europe to clear Leqembi, but NICE says n...

FDA kicks off review of Takeda's narcolepsy hopeful

How to meet your physicians where they are online

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