Nuvalent filed a new drug application for an experimental non-small cell lung cancer treatment with the Food and Drug Administration.
Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026If approved, ZORYVE cream 0.3% would be the first and only topical ...
The call is coming from inside the house: Top FDA drug regulator Richard Pazdur, who was appointed to the role earlier this month, has raised alarms about the agency’s various plans to expedite drug ...
NDA based on data from global ARROS-1 Phase 1/2 clinical trial FDA assigns PDUFA target action date of September 18, 2026 CAMBRIDGE, Mass., Nov. 19, 2025 /PRNewswire/ ...
Nuvalent (NUVL) announced the FDA has accepted for filing its New Drug Application, or NDA, for zidesamtinib, an investigational ROS1-selective ...
Three Republican-led states have challenged the Food and Drug Administration’s (FDA) approval of a generic form of the ...
GSK remains committed to the relaunch of BREXAFEMME, and following its relaunch, SCYNEXIS stands to receive up to $145.5 million in annual net sales milestones as well as royalties, net of payments to ...
Silo Pharma, Inc. (Nasdaq: SILO) ('Silo” or 'the Company), a diversified developmental-stage biopharmaceutical and ...
The Inflation Reduction Act (IRA) of 2022 mandates price negotiations for certain drugs under Medicare, shortening the exclusivity period historically used to recoup research and development ...
Arcutis aims to expand its market reach with new approvals. Management recently pleased the market with its sales guidance ...
Cytokinetics, Incorporated awaits a pivotal FDA decision on aficamten for hypertrophic cardiomyopathy. Learn more about CYTK ...
The Food and Drug Administration (FDA) has issued a statement, published electronically in the New England Journal of ...
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