The US Food and Drug Administration (FDA) has published two final guidances for generic drug sponsors that the agency says will streamline the premarket review and approval process. On 24 January, FDA ...
Generic drug makers received a final and a draft guidance from the US Food and Drug Administration (FDA) on 28 September that address components of the submission process for an abbreviated new drug ...
Lupin’s ANDA received tentative FDA approval for four enzalutamide tablet strengths, with final approval deferred until ...
WILMINGTON, Del., Dec. 02, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration ...
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