For many women who experience hot flashes, the new drug Veozah has been a life-changer. And a heightened warning last month, doesn’t seem to be dampening that enthusiasm.
Menopause is a huge mental, emotional and physical change. Here's what you need to know about this stage of life, including ...
Thursday, Bayer shared top-line data from a phase 3 trial that tested elinzanetant in women on adjuvant endocrine therapy for breast cancer. The anticancer therapy can cause hot flashes, known ...
The Food and Drug Administration (FDA) gave the green light to the the first-ever medication for obstructive sleep apnea (OSA). The newly approved drug, Zepbound (tirzepatide), targets adults with ...
Almost exactly 10 years after the FDA’s initial FDA approval for Bristol Myers Squibb’s Opdivo as the first PD-1 inhibitor in the U.S., the agency has cleared an under-the-skin version of the ...
Ryoncil, the first mesenchymal stromal cell therapy, showed a 70% overall response rate in pediatric steroid-refractory acute GVHD, with a median DOR of 54 days. The FDA approved several drugs in ...
Subcutaneous nivolumab and hyaluronidase-nvhy is FDA-approved for adult solid tumors, offering a new administration route for PD-1 inhibitors. The phase 3 CheckMate-67T trial confirmed ...
The US Food and Drug Administration has placed its most serious alert — a so-called black-box warning — on a drug used to relieve menopausal hot flashes. The menopause drug Veozah hit the ...
The Food and Drug Administration (FDA) on Dec. 20 approved the obesity medication Zepbound (tirzepatide) as the first pharmaceutical treatment for moderate-to-severe obstructive sleep apnea (OSA) in ...
The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new small molecules, biologics and oligonucleotide therapeutics last year. The class of 2024 was a little smaller than that ...
The expanded approval was based on data from a randomized, placebo-controlled, double-blind, parallel-group study (ClinicalTrials.gov Identifier: NCT05274269) that included 307 patients aged 6 ...
and it is approved for some non-small cell lung cancers in the first- and second-line settings. The FDA is also reviewing another biologics license application from BeiGene seeking Tevimbra's approval ...