Tag Archives: scores

Albireo’s rare liver disease drug Bylvay scores back-to-back approvals in U.S., Europe

With a pair of approvals on both sides of the Atlantic, liver disease-focused biotech Albireo is off and running with its new medicine Bylvay. The oral drug, the first treatment for pruritus in patients with progressive familial intrahepatic cholestasis (PFIC), scored an FDA nod Tuesday and a European approval Monday. With the FDA’s blessing, Albireo is kicking off an “immediate”… Read More »

Kadmon’s Rezurock scores surprise FDA nod in chronic graft-versus-host-disease

With a surprise FDA approval Friday afternoon, Kadmon Holdings is on its way to becoming a commercial drugmaker.  The FDA cleared Kadmon’s Rezurock to treat chronic graft-versus-host disease, a serious complication of transplant procedures. Formerly known as belumodsil, the drug is a first-in-class ROCK2 inhibitor—and now Kadmon’s first approved drug.  GVHD occurs when donor cells mount an immune response against a patient’s own tissues and organs. While doctors can… Read More »

Johnson & Johnson’s COVID-19 vaccine scores longer shelf life just as millions of doses were set to expire

Just as states were scrambling to administer millions of Johnson & Johnson COVID-19 doses set to expire by the end of June, the FDA has swooped in to give the jabs a bit more time on the shelf. The U.S. FDA has extended the shelf life for J&J’s single-shot vaccine from three months to four and… Read More »