News FDA fast-tracks Teva's coeliac disease treatment Teva gets fast-track status from the FDA for a coeliac disease drug with a mechanism that has proved tough to crack.
News Manufacturing issues scupper Savara's lead drug filing Savara shares are pummelled after the FDA says it cannot accept a filing for lead drug Molbreevi, but it is still hopeful of an approval in 2026.
News FDA tightens heart tox warnings on mRNA COVID vaccines The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity.
News Mixed outcomes for pharma in big week for FDA adcomms There was good news for Johnson & Johnson at this week's ODAC meetings, but not for Roche, UroGen, and Pfizer.
News US imposes limits on COVID-19 boosters and new jabs The FDA has introduced a stricter set of policies around COVID-19 vaccines, including requiring clinical trials for new shots in some cases.
News O'Shaughnessy says UK clinical trials sector is on the mend After losing ground in commercial clinical trials in recent years, the UK has now turned a corner and is once again taking a "global lead."
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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