Last year CDER approved 37 new drugs never before approved or marketed in the U.S., known as “novel” drugs, as noted in its annual New Drug Therapy Approvals report. The agency also approved drugs in new settings, such as for new uses and patient populations.
Tag Archive for: lupus nephritis
Novartis reported Thursday that a Phase III trial of iptacopan met its primary endpoint in paroxysmal nocturnal hemoglobinuria (PNH) – the company’s second win in this indication in as many months.
And then there were two. Janssen (Johnson & Johnson) is no longer in the running to acquire rare disease player Horizon Therapeutics, the company announced Saturday.
Bristol Myers Squibb (BMS) announced late-breaking data Wednesday showing that deucravacitinib, an allosteric tyrosine kinase 2 inhibitor, met the primary endpoint in the treatment of systemic lupus erythematosus.