FDA
FDA inspectors warned UCSF radiopharmaceutical facility that losing environmental control could pose a serious hazard to patients.
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After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.
BioSpace looks back at 2025 and where the FDA is going in 2026.
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
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The third time is the charm for AstraZeneca and its hyperkalemia treatment that has been dogged by manufacturing issues. After multiple rejections, the U.S. Food and Drug Administration finally gave its approval for the treatment.
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.