News Intercept pulls Ocaliva off the market in the US Alfasigma's $800m buyout of Intercept is starting to look like a poor bet as its only product, Ocaliva, is pulled from the market.
News RFK Jr revives childhood vaccine task force HHS Secretary Kennedy adds yet another layer of scrutiny to childhood vaccines with the re-establishment of a task force disbanded in the 1990s.
News FDA restricts use of bluebird's Skysona gene therapy The FDA has added a warning label to bluebird bio's Skysona, after launching a probe into cases of blood cancer linked to the gene therapy.
News FDA gives the go-ahead to restart Elevidys shipments Sarepta has restarted distribution of its Duchenne muscular dystrophy gene therapy Elevidys, but only for patients who can walk.
News Sarepta backs down and pauses Elevidys shipments The FDA seems to have won its staring contest with Sarepta over shipments of Elevidys, as the company blinks and agrees to a pause from today.
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 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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