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Amgen's BiTE for lung cancer backed for EU approval

Amgen's fast-growing bispecific T-cell engager Imdylltra should be cleared as a second-line therapy for small cell lung cancer, said the CHMP.

Market Access

A panel on direct-to-patient at Reuters Pharma USA

In DTC's watershed moment, trust and partnership are key

More and more pharma companies are turning to direct-to-patient access models. But the consensus at Reuters Pharma USA is that they can't do it alone.

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Amgen baulks at FDA request to withdraw Tavneos

Amgen confirmed on its fourth-quarter results call that it has resisted a request to pull Tavneos for ANCA-associated vasculitis from the US market.

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Bottle of Tavneos with two pills in front of it

EMA looks into 'data integrity' issue with Amgen's Tavneos

Concerns about efficacy data in the main trial behind the approvals of Amgen and CSL Vifor's Tavneos have triggered a review in the EU.

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Amgen inks $840m takeover of UK's Dark Blue Therapeutics

Amgen has added a new acute myeloid leukaemia drug with the takeover of Dark Blue Therapeutics and its first-in-class MLLT 1/3 degrader.

News

Nine more companies sign pricing deals with Trump

Nine more pharma groups have agreed to lower the costs of medicines in the US under the Trump administration's most favoured nation (MFN) scheme.

Amgen's BiTE for lung cancer backed for EU approval

In DTC's watershed moment, trust and partnership are key

Amgen baulks at FDA request to withdraw Tavneos

EMA looks into 'data integrity' issue with Amgen's Tavneos

Amgen inks $840m takeover of UK's Dark Blue Therapeutics

Nine more companies sign pricing deals with Trump

LSX2026: On promise and patience, with Hans Schambye

Using AI-driven synthetic personas to take your insights fur...

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