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.
Because of this definition, they have not been subject to reports of efficacy and adverse events compared with US FDA-approved hormones ... Evidence for Relief of Hot Flashes & Vaginal Dryness ...
Acalabrutinib received FDA approval for MCL as monotherapy and in combination with bendamustine and rituximab. The ECHO trial showed a 27% reduction in death risk and 34% improvement in ...
As supported by data from the phase 3 TROPION-Breast01 trial, datopotamab deruxtecan is now an FDA-approved treatment for patients with HR-positive, HER2-negative breast cancer. The FDA has approved ...
A government watchdog examining the FDA’s accelerated approval pathway has released a 32-page report (PDF) that concludes the agency’s controversial endorsement of Biogen’s failed Alzheimer ...
Autolus has picked up its first product approval, getting an FDA green light for Aucatzyl as a treatment for patients with aggressive blood cancer acute lymphoblastic leukaemia (ALL). The US ...
The approval is based on findings from the phase 3, multicenter, open-label, randomized TROPION-Breast01 trial. Today, the FDA approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo ...
The authorization does not mean the products are safe or “FDA approved,” however. Perspective from Johannes Thrul, PhD The FDA announced it has authorized the marketing of 20 Zyn nicotine ...
FDA approves Zyn nicotine pouches, including 10 flavors, as a safer option for adult smokers. The decision marks the first FDA authorization for nicotine pouches, which are tobacco-free.