Sobi’s plan to introduce a challenger to Amgen’s blockbuster gout drug Krystexxa has been put on hold by the FDA. | Sobi’s plan to introduce a challenger to Amgen’s blockbuster gout drug Krystexxa has been put on hold by the FDA.
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The FDA has issued Sobi, also known as Swedish Orphan Biovitrum, a complete response letter for its combination gout treatment…
As Amgen prepares to defend Tavneos’ market approval in the U.S., the company has received a bad omen overseas, with regulators…
With a new patent settlement, Axsome Therapeutics can lower its sword against prospective generics makers taking aim at its…
After a prior misfire in demonstrating its protease inhibitor ensitrelvir’s potential as a COVID-19 treatment for U.S. | After a…
Three times as many deaths in the study arm versus the control arm in a trial of ADC Therapeutics' Zynlonta have raised questions…
GSK and Spero Therapeutics have scor | Four years after Spero Therapeutics received a complete response letter from the FDA,…
