Concerns the Galapagos-partnered JAK inhibitor would be held back by a testicular toxicity study have been calmed by positive FDA talks and a submission is due before the end of the year.
The US filing for rheumatoid arthritis (RA) of Gilead Sciences Inc. and Galapagos NV's closely watched filgotinib is now expected by the end of this year, allaying fears that the drug would be at a competitive disadvantage to AbbVie Inc.’s already-submitted rival JAK inhibitor upadacitinib.
Gilead has announced that it has held a pre-submission meeting with the US Food and Drug Administration to provide an...
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A late-stage win in the ALLEGORY study in SLE supports Roche’s push to expand Gazyva beyond oncology and into autoimmune diseases.
The Swiss major plans to submit the positive results from the NEPTUNUS program to health authorities globally in early 2026.
The departing CEO announced improved full-year sales and profit forecasts before handing over to Luke Miels in January; he will then have to deliver on GSK’s upgraded forecast of £40bn revenues in 2031.
With a novel mechanism of action that potentially improves tolerability and retreatment flexibility, and now armed with promising Phase II data, Zenas could be set to take on some massive competition.
Novo Nordisk’s high-dose semaglutide for obesity and Lilly’s oral obesity candidate orforglipron were given priority review vouchers by the US Food and Drug Administration.
The US pharma giant may have a best-in-class amylin agonist to go with incretin blockbuster Zepbound, but challengers could still go one better on safety and tolerability.
Wegovy and Zepbound will cost around $250 per month under Medicare and Medicaid, and the drugs will cost around $350 per month through TrumpRx.
