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FDA sets out its thinking on protecting children in clinical...

The FDA has published draft guidance giving its position on the ethical reasons for including children in clinical trials, and protecting them from harm.

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FDA panel shoots down Spectrum, Oncopeptides' cancer drugs

Chances of FDA approval for Spectrum Pharma's lung cancer candidate poziotinib and Oncopeptides' Pepaxto for multiple myeloma have taken a dive, after the regulator's expert advisors voted

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Helping to support momentum on antimicrobial innovation

Undeterred by FDA setback, GSK snaps up Spero antibiotic

GSK is paying $66 million upfront to license rights to Spero Therapeutics novel antibiotic tebipenem Hbr, unswayed by the FDA's decision earlier this year not to approve the drug for adults

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GSK's daprodustat will have to face FDA advisory committee

GSK has said that its daprodustat for anaemia associated with chronic kidney disease (CKD) will have to face an FDA advisory committee before the US regulator delivers a verdict on the drug

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Xenpozyme is first FDA-approved drug for rare disease ASMD

Sanofi now has approval on both sides of the Atlantic for Xenpozyme – its enzyme replacement therapy for rare disease acid sphingomyelinase deficiency (ASMD) – after getting a green light f

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