Supported by phase 3 OASIS-4 data, elinzanetant significantly reduced daily hot flash frequency in women receiving endocrine therapy for HR-positive breast cancer.

Juvmo (tavapadon) offers a novel, selective D1/D5 dopamine receptor partial agonist mechanism for early monotherapy and adjunctive treatment in Parkinson disease.

Phase 3 trial data show significant scalp, eyelash, and eyebrow hair regrowth at 36 weeks in adolescents treated with oral baricitinib.

Advisers split on whether Galleri, which screens for more than 50 cancers, catches disease early enough to save lives.

The FDA has accepted and granted Priority Review to an application for lower doses of leniolisib to treat younger children with activated phosphoinositide 3-kinase delta syndrome.

Topline phase 3 findings show the KIT receptor inhibitor barzolvolimab significantly reduced itch and hives while achieving high complete response rates in patients with chronic spontaneous urticaria.

Approval of the nonsteroidal mineralocorticoid receptor antagonist provides the first new treatment option in over 30 years for kidney disease in adults with type 1 diabetes.

The intravenous immune globulin replacement therapy is currently being evaluated in a phase 3 clinical trial assessing motor function and mobility in adult patients with stiff person syndrome.

The FDA approved Bravnetsa as the first radioligand therapy through the Abbreviated New Drug Application pathway, offering a bioequivalent alternative to Lutathera for adult patients with ...

Probiotic supplement use has surged in the United States, while the consumption of microbiome-supportive foods has remained unchanged, according to a study publ ...

Approval is supported by phase 3 INShore trial data demonstrating 95% sustained complete remission at 52 weeks with obinutuzumab compared with 73% with MMF.

Routine FDA testing found patulin above safety limits in Wholesome Pantry jars sold at ShopRite and four other chains ...