regulatory approval

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China clears ViiV, J&J injectable HIV treatment

ViiV Healthcare and Johnson & Johnson have been granted approval in China for a long-acting HIV therapy that frees patients from the need to take daily pills to keep t

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FDA clears Servier's Tibsovo as first targeted drug for MDS

Servier has become the first company to get US approval for an IDH inhibitor as a treatment for myelodysplastic syndromes (MDS) after its Tibsovo drug was cleared by the F

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Keytruda gets surgery-spanning OK from FDA in early NSCLC

MSD’s Keytruda has become the first immunotherapy in the US that can be used continuously, before and after surgery, in patients with early-stage non-small cell lung cance

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Novavax gets green light for updated COVID vaccine

Novavax has been given the go-ahead by regulators in the US for an updated version of its COVID-19 vaccine that targets the XBB.1.5 variant of the coronavirus.

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Biogen claims first with FDA nod for biosimilar Actemra

Biogen says it is the first drugmaker in the US to get FDA approval for a biosimilar of Roche’s $3 billion blockbuster product Actemra.

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Leqembi approved in Japan, its first ex-US market

Eisai and Biogen now have their second regulatory approval for anti-amyloid therapy Leqembi – in Japan – as a treatment for slowing the progression of Alzheimer’s disease.

China clears ViiV, J&J injectable HIV treatment

FDA clears Servier's Tibsovo as first targeted drug for MDS

Keytruda gets surgery-spanning OK from FDA in early NSCLC

Novavax gets green light for updated COVID vaccine

Biogen claims first with FDA nod for biosimilar Actemra

Leqembi approved in Japan, its first ex-US market

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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