Replimune Group's RP1 oncolytic virus therapy faced an FDA rejection, raising concerns about the platform's viability in ...

One of the most notable accomplishments of the first Trump Administration was its willingness to take on the status quo of ...

Join our comprehensive FDA regulatory course to navigate submissions for INDs, NDAs, ANDAs, and 505(b)(2). Gain insights into FDA processes, recent changes, and strategic needs, featuring expert-led ...

CMS often withholds coverage for reimbursement, disrupting the natural flow of the market and hindering access to proven ...

FDA Commissioner Marty Makary said the FDA’s review process will not slow down despite layoffs at the Department of Health ...

FDA Commissioner Marty Makary said at a press conference Tuesday that the federal government is beginning to process to ...

On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ ...

Designed to expand PSMA PET imaging access for patients by increasing batch size by ~50% and enhancing supply resilience PDUFA date set for March 6, 2026 BEDFORD, Mass., Aug. 06, 2025 (GLOBE NEWSWIRE) ...

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

The Commissioner’s National Priority Vouchers aim to offer accelerated pathways to drugs that meet certain criteria, perhaps ...

The prefilled syringe presentation offers a convenient administration option to healthcare professionals.

The FDA accepted a supplemental application for Breyanzi to treat adults with relapsed or refractory marginal zone lymphoma ...