The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments addressing ultrarare diseases. The FDA unveiled draft guidance on a proposed ...
SUNNYVALE, Calif., April 02, 2026 (GLOBE NEWSWIRE) -- BioCardia ®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary ...
With a goal of avoiding unnecessary duplication of studies performed on a previously approved drug, the 505(b)(2) pathway allows for a more streamlined development and approval process, but for new ...
San Diego – Officials from the European Medicines Agency (EMA) discussed the different types of expedited approval pathways available to sponsors of innovative drugs and advanced therapy medicinal ...
Late on Wednesday, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary and Center for Biologics Evaluation & Research (CBER) Director Vinay Prasad published an article in the New England ...
In the second part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss the regulatory pathways for biological products under Section 351 of the Public Health Service ...
(The Hill) — The Food and Drug Administration (FDA) on Monday announced a new proposal for flexible drug approval pathway treatments addressing ultra-rare diseases. The FDA unveiled draft guidance on ...
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