FDA
Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite assurances of swift reviews under the FDA’s new Commissioner’s National Priority Voucher program.
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After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
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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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).