The Inflation Reduction Act (IRA) of 2022 introduced substantial changes to Medicare, specifically developing the Medicare Drug Price Negotiation Program (DPNP). As part of this program, the Centers ...

James V. Caruso, President and CEO, stated that Cellectar has made "significant strides across our development pipeline, regulatory strategy, corporate development initiatives and fundraising efforts, ...

CEO Rick Stewart stated that "Achieve is on track to submit the NDA for cytisinicline next month." He emphasized that "all internal resources are now focused on a successful NDA submission, acceptance ...

Cytokinetics, Incorporated announced that the FDA has extended the action date for aficamten, a treatment for obstructive hypertrophic cardiomyopathy (oHCM), to December 26, 2025. The extension is due ...

Reports positive pharmacokinetic (PK) results from the recently completed pediatric study for Anaphylm™ Completes submission of its New Drug Application (NDA) for Anaphylm to the FDA; NDA acceptance ...

The Prescription Drug User Fee Act target guidelines for NDA resubmissions include acknowledgment of acceptance for review within 30 days of submission, and completion of submission review within 6 ...

PRINCETON, N.J.--(BUSINESS WIRE)-- UroGen Pharma Ltd. (Nasdaq: URGN), a leading biotech company specializing in novel therapies for urothelial and specialty cancers, today announced the successful ...