FDA rejects Vanda’s jet lag drug in current form

Vanda strongly disputes the FDA’s reasoning

Diabeloop bags FDA nod for DBLG2, opens US market for automated insulin delivery

The clearance marks a major step in Diabeloop’s ambition to become a central partner for insulin pump manufacturers and expand access to automated insulin delivery in the US market

Halozyme and Takeda team up to transform Crohn’s and Colitis Therapy

The agreement, signed in December 2025, grants Takeda an exclusive worldwide license to use Halozyme’s proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20) with vedolizumab

InflaRx shifts focus to lead drug, cuts costs by 30% to extend cash runway

InflaRx is streamlining operations and largely discontinuing non-essential activities outside izicopan’s development

GSK reports breakthrough results in chronic hepatitis B trials

Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations

Subcutaneous Saphnelo cuts lupus disease activity in phase III trial

SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage

FDA grants priority review to Tzield for youngest Type 1 diabetes patients

Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D

Medera doses final patient in high-dose HFpEF gene therapy trial

Heart failure affects an estimated 64.3 million people worldwide

BioInvent’s experimental combo shows promise in hard-to-treat ovarian cancer

Pembrolizumab has shown meaningful benefit only when combined with chemotherapy