News FDA names a new CDER director, choosing a biotech vet The FDA has rounded out its senior leadership by naming biopharma industry executive George Tidmarsh to the role of CDER director.
News First-in-class hay fever immunotherapy backed for NHS use A once-daily tablet that can help people suffering from hay fever caused by tree pollen, Alk-Abelló's Itulazax, has been recommended for NHS use.
News Merck's SpringWorks takeover delivers a drug approval Merck gets another quick return on its $3.9bn SpringWorks takeover with EU approval of Ezmekly for tumours caused by neurofibromatosis type 1.
News Sarepta resists as FDA seeks pause on Elevidys use Sarepta has defied an FDA request to halt all use of its gene therapy for Duchenne muscular dystrophy, creating an intriguing regulatory impasse.
News GSK's growth plans dented by Blenrep setback FDA advisors have voted that the benefit/risk profile of GSK's multiple myeloma therapy, Blenrep, does not support its approval in the US.
News NICE relents and backs Kisqali for wide use in breast cancer Novartis' breast cancer therapy Kisqali has been cleared for NHS use in early breast cancer, an indication driving blockbuster sales of the drug.
News Lilly UK recruits ex-England cricketer as obesity champion Lilly UK's obesity champion Ashley Giles, who won the Ashes with England in 2005, is urging people struggling with their weight to ask for help.
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