"As the first and only FDA-approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis in chronic GVHD, Niktimvo represents a major breakthrough for patient care," said ...

FoundationOne CDx is now FDA-approved as the first companion diagnostic for tovorafenib, enabling targeted treatment for relapsed/refractory pediatric low-grade glioma with BRAF mutations or ...

Avutometinib and defactinib target KRAS-mutated recurrent low-grade serous ovarian cancer, potentially becoming the first FDA-approved treatment for this specific cancer type. The NDA is supported by ...

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 ...

The FDA approved several drugs in December for the treatment of diseases, including pancreatic adenocarcinoma, lung cancer, skin cancer and graft-versus-host disease. Throughout December, the Food and ...

The first medication for obstructive sleep apnea has been approved by the US Food and Drug Administration (FDA). On Dec. 20, the FDA announced that the agency has approved Eli Lilly’s Zepbound ...

In a statement sent to Fox News Digital, Joshua Murdock, PharmD, pharmacy editor at GoodRx, commented on the "significant number" of already-approved medications that were approved for new uses in ...

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 ...

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.

The FDA is reviewing the resubmitted NDA for SPN-830, an apomorphine infusion device for the continuous treatment of motor fluctuations (“off” episodes) in adults with Parkinson disease. SPN-830 ...

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 ...