News Re-rostered FDA committee backs peptide compounding Against the advice of FDA staff scientists, an advisory committee has narrowly voted in support of looser restrictions on compounded peptides.
News Dexcom is first to join FDA/CMS health tech pilot The FDA has named Dexcom as the first company to take part in its TEMPO pilot, which aims to bring digital health tech to patients more quickly.
News Kaken details the data behind its PI3K inhibitor filing Kaken has revealed the data that supported its recent marketing application for serabelisib as a treatment for vascular malformations in Japan.
News EU warns of brain tumour risk with some contraceptives EU pharmaceutical safety advisers have said that commonly used contraceptives may carry a small risk of a type of brain cancer with prolonged use.
News Newron charts course forward for stalled schizophrenia drug Newron thinks it may have reached an agreement with the FDA on a way to get the US development of its schizophrenia candidate evenamide back on track.
R&D Parexel: Flawless execution, policy shifts & patient-centric... Parexel's Paul Bridges & Charlotte Moser discuss Europe's biotech sector in the face of an innovation cliff.
News Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer Eli Lilly's imlunestrant (Inluriyo) for breast cancer has received a new FDA approval, in combination with CDK4/6 inhibitor abemaciclib (Verzenio).
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