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Roche has been awarded breakthrough status for a drug that has shown some signs of activity in autism spectrum disorders, according to reports.
Amgen and Novartis' migraine drug hit its endpoints in a study of patients who have failed multiple treatments.
Drugmakers cannot file regulatory submissions that require the payment of a fee until politicians pass a bill to fund the federal government.
The Broad Institute just lost the latest skirmish over ownership of the intellectual property surrounding the gene-editing CRISPR/Cas9 technology.
Gottlieb talked up the prospect of releasing redacted CRLs in his confirmation hearings but has now watered down his interest in the idea.
We catch up with Doug Ingram, chief at rare disease biotech Sarepta, and discuss how he aims to remove the term “controversial” in front of the company’s name.
Describing a country as a “shithole” isn’t going to endear you to anyone, but President Trump’s latest alleged outburst has struck a nerve with one particular…
The setback leaves Concert committed to taking the drug forward in alopecia areata but uncertain of its future beyond the indication.
The panel felt Aradigm failed to show evidence of the safety and efficacy of Linhaliq in delaying the first exacerbation in chronic lung infections.
The panel voted 13-6 against the risk-benefit profile of Tlando, leaving Lipocine looking at a rejection.