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 ...

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 ...

A study published by the North American Menopause Society in the journal Menopause, found a plant-based diet rich in soy reduces moderate-to-severe hot flashes by 84%, from nearly five per day to ...

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 ...

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 ...

In its second attempt, Takeda has secured FDA approval for Eohilia, which becomes the first and only oral therapy in the US for eosinophilic oesophagitis (EoE). The US regulator has cleared ...

The FDA grants orphan status to medicines and biologics for rare diseases that meet certain criteria, opening the way for incentives such as accelerated approval and tax breaks to support their ...

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 combination of encorafenib (Braftovi), cetuximab (Erbitux), and chemotherapy for BRAF V600E-positive metastatic colorectal cancer was also approved by the FDA, as well as subcutaneous nivolumab ...

For many people, the end of the year is a mad rush to wrap things up before the holidays, and so it was for the FDA. Notable regulatory decisions include the first drug approval for a prevalent ...

2 decision deadline, and extends Vertex’s dominance in the lung disease cystic fibrosis. Prior to Alyftrek’s approval, Vertex had previously brought four cystic fibrosis medicines to market, building ...