Policy
The FDA’s drug review process can often be “unpredictable,” and review teams typically “differ greatly” in what they ask of drug sponsors, Sen. Bill Cassidy said.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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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