Acoramidis is the first FDA-approved treatment for ATTR-CM with near-complete TTR stabilization, reducing cardiovascular death and hospitalization. The phase 3 ATTRibute-CM trial showed acoramidis ...

Following the U.S. Food and Drug Administration extending the review period for the company's New Drug Application (NDA) for ...

Regulatory policies influence the availability of affordable biosimilars, with varying impacts across different jurisdictions ...

Elanco is an animal health company that develops products for pets and farm animals, including Zenrelia, an oral Janus kinase inhibitor for canine dermatology, and Credelio Quattro, a parasiticide for ...

James Seyffart predicts late 2025 for potential SEC approval of SOL, XRP, LTC, HBAR ETFs. WisdomTree, 21Shares file for XRP ETFs, pending SEC review under current regulations. Bloomberg's Seyffart ...

Embryo-Fetal Toxicity ZIIHERA can cause fetal harm when administered to a pregnant woman. In literature reports, use of a HER2-directed antibody during p ...

Resubmission addresses questions raised in January 2024 Complete Response LetterF8 formulation intended to replace EGRIFTA SV® with simplified ...

At its second attempt, Astellas has won FDA approval for its first-in-class cancer therapy, Vyloy, which got the green light for certain gastric cancers. The US regulator approved Vyloy ...

There are currently no FDA- or EMA-approved treatment options available for any form of frontotemporal dementia.