Policy
The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.
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Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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Tetra Natural Health a wholly owned subsidiary of Tetra Bio-Pharma Inc., announced that it has submitted two over-the-counter DIN applications to Health Canada.
Avadim Health, Inc. announced that it has confidentially submitted a draft registration statement on Form S-1 to the U.S. Securities and Exchange Commission relating to the proposed initial public offering of its common stock.
Tetra Bio-Pharma Inc., announced that the U.S. Food and Drug Administration has authorized the advancement of Plenitude, the company’s clinical trial for its investigational therapeutic QIXLEEF™, for the treatment of uncontrolled pain in advanced cancer patients.
NDA supported by positive interim analysis results from the Phase 3 REGENERATE study demonstrating OCA’s improvement of liver fibrosis without worsening of NASH
NDA supported by data from two pivotal Phase 3 trials in Dravet syndrome, both of which met the primary and all key secondary endpoints, and an interim analysis from an ongoing open-label extension study
Adamis Pharmaceuticals Corporation today announced that after the close of U.S. markets on November 22nd, it received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for Adamis’ ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose.
SK Life Science, Inc. Receives US FDA Approval for cenobamate tablets for the Treatment of Partial-Onset Seizures in Adults with Epilepsy
Filing submission includes 12-month data from pivotal FIREFISH and SUNFISH trials in a broad population of people living with Types 1, 2 or 3 SMA
ZimetaTM should not be used more frequently than every 12 hours. For use in horses only. Do not use in horses with a hypersensitivity to dipyrone, horses intended for human consumption or any food producing animals, including lactating dairy animals.
First and only FDA-approved sickle hemoglobin polymerization inhibitor, a new class of therapy