FDA
Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
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Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Amgen and Novartis scored a big win in the migraine market late Thursday when the U.S. Food and Drug Administration approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults.
U.S. Food and Drug Administration approved a new treatment to help patients manage withdrawal symptoms from opioid addiction.
The U.S. Food and Drug Administration (FDA) approved Pfizer’s Retacrit (epoetin alfa-epbx), a biosimilar to Amgen’s Epogen/Procrit (epoetin alfa). The drugs treat anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in HIV patients.
There are a few upcoming approval dates for several companies this week. Let’s take a look at the companies and their products awaiting approval.
The U.S. Food and Drug Administration (FDA) granted Genentech’s Tecentriq triple combination with Avastain (bevacizumab), paclitaxel and carboplatin (chemotherapy) Priority Review for first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC).
Approximately 25 percent of adults in the United States will deal with some form of mental illness within a given year. It’s also estimated that many of the people who experience these problems may never report it or seek help.
The U.S. Food and Drug Administration (FDA) approved Portola Pharmaceuticals’ Andexxa, an antidote for blood thinners rivaroxaban and apixaban.
According to Biosimilarpipeline, more than 660 companies worldwide have about 700 biosimilars in development.
Shares of Newton, Mass.-based Karyopharm Therapeutics is skyrocketing in premarket trading after the company announced late Monday it will seek U.S. Food and Drug Administration approval for its investigational drug selinexor following strong top-line results from a Phase IIb trial.
The U.S. Food and Drug Administration (FDA) cleared Haifa, Israel-based Pluristem Therapeutics’ Investigational New Drug (IND) application for PLX-R18 to treat acute radiation syndrome (ARS).