In today’s ACT Brief, we examine how the FDA’s CNPV Program is reshaping operational planning and accelerated submission ...
FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.
In this Q&A, John Kirk, principal regulatory specialist at Veristat, explains how the FDA’s Commissioner’s National Priority ...
The FDA’s new Commissioner’s National Priority Voucher signals a transformative shift in U.S. drug review, tying accelerated approval to manufacturing readiness, domestic supply-chain strength, and ...
CEO Robert Blum emphasized the company's progress toward the potential commercialization of aficamten, noting the FDA's extension of the PDUFA date to December 26, 2025, to review a submitted REMS ...
Analysts at Guggenheim Partners expect Voyxact to see “broad commercial uptake” given its relatively broad label compared ...
FDA lowers surveillance requirement to 50 patients from 300 patients in original HDE approval based on assessment of first 21 SAVE Surveillance Registry patients ...
The President Donald Trump administration’s request for Novavax Inc. (NASDAQ:NVAX) to conduct new clinical trials for its COVID-19 vaccine. What Happened: Novavax announced Monday that the Food and ...
"Powerful" new treatments for various types of cancer and neurodegenerative disorders, such as Alzheimer's, Parkinson's, and ...
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Arrowhead Pharmaceuticals’ Earnings Call Highlights FDA Approval and Strong Financials
Arrowhead Pharmaceuticals, Inc. (($ARWR)) has held its Q4 earnings call. Read on for the main highlights of the call. The recent earnings call for ...
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