The approval marks the therapy as the first and only menin inhibitor for treating patients one year and older with relapsed or refractory acute leukaemia with KMT2A ...

Nearly a year after receiving federal approval to import lower-cost prescription drugs from Canada, Florida's ambitious ...

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 ...

Autolus’ Aucatzyl is a B-lymphocyte antigen CD19 CAR-T cell therapy. Credit: NDAB Creativity via Shutterstock. Autolus Therapeutics has secured US Food and Drug Administration (FDA) approval for ...

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 ...

The pilot by the FDA’s CDRH will improve communications about corrective actions being taken over certain medical device ...

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 ...

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 ...

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 ...