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FDA launches pilot programme to boost US manufacturing

The FDA has started accepting requests to participate in its PreCheck pilot programme, promising rapid reviews of new manufacturing facilities.

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UCB closes on first EU OK for TK2d therapy

UCB gets an EU recommendation for the first therapy for thymidine kinase 2 deficiency (TK2d), plus other CHMP decisions.

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Lilly names Pennsylvania site for its latest US facility

Eli Lilly has revealed the fourth new manufacturing site in its $27 billion capital investment spree in the US - a $3.5bn facility in Pennsylvania.

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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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FDA starts review of Summit's VEGFxPD-1 bispecific

Summit moves ahead in the race to bring a VEGFxPD-(L)1 drug to market, after the FDA started a review of ivonescimab in lung cancer.

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Tenpoint eyes presbyopia drug launch after FDA nod

Tenpoint is set to join the US market for drugs to treat presbyopia, taking on rival therapies from AbbVie, Orasis, and LENZ with a dual-acting rival.

FDA launches pilot programme to boost US manufacturing

UCB closes on first EU OK for TK2d therapy

Lilly names Pennsylvania site for its latest US facility

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

FDA starts review of Summit's VEGFxPD-1 bispecific

Tenpoint eyes presbyopia drug launch after FDA nod

AI specialist Chai Discovery raises $400m

Discover a new era of healthcare panel engagement: Grounded ...

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