regulatory approval

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Imfinzi faces Keytruda competition in biliary tract cancer

MSD’s PD-1 inhibitor Keytruda has been approved by the FDA as a treatment for locally advanced unresectable or metastatic biliary tract cancer (BTC) in combination with ch

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FDA clears Roche’s Vabysmo for retinal vein occlusion

Roche has claimed a third approval from the FDA for its eye disease therapy Vabysmo – already its fastest-growing product – that could make it an option for hundreds of th

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Lilly finally gets FDA OK for ulcerative colitis drug Omvoh

After an earlier rejection, the FDA has approved Eli Lilly’s first-in-class IL-23p19 inhibitor mirikizumab as a treatment for adults with moderately to severely active ulc

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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

Imfinzi faces Keytruda competition in biliary tract cancer

FDA clears Roche’s Vabysmo for retinal vein occlusion

Lilly finally gets FDA OK for ulcerative colitis drug Omvoh

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

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regulatory approval

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