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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After a delay in review, the FDA approved Acorda’s Inbrija for the intermittent treatment of OFF episodes of Parkinson’s.
Alexion Pharmaceuticals and Stemline Therapeutics both secured FDA approval for their drugs.
Bavarian Nordic A/S today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for the liquid-frozen version of the MVA-BN®for active immunization against smallpox in adults age 18 years and older.
Merck & Co. found itself with two new approvals this week. The FDA approved Lynparza (codeveloped by AstraZeneca and Merck) and also approved Merck’s Keytruda. Both of these drugs were approved for new indications.
With the holidays upon us, along with the end of 2018 and the beginning of 2019, the FDA squeezed some target action dates into the last weeks and beginning of the new year. As it turned out, these appear to be a mixed bag of extensions, resubmissions and supplemental applications, some of which are still pending while others have been approved earlier. Here’s a look.
AC5™ provides a new option for the treatment of topical wounds
Intuitive and Discreet Device Provides Sacral Neuromodulation Therapy for Overactive Bladder and Bowel Incontinence
The U.S. Food and Drug Administration approved another biosimilar. On Friday, the regulatory agency approved Herzuma, a biosimilar to Genentech’s Herceptin developed by South Korea-based Celltrion, Inc. and Israel-based Teva Pharmaceuticals.
As the holidays approach, the U.S. Food and Drug Administration (FDA) is getting in a few drug approvals to wrap up the year. This week there are two decision dates, with another that has been delayed for several months. Here’s a look.
In writing literally hundreds of stories this year, two BioSpace writers, Alex Keown and Mark Terry, found certain stories particularly intriguing or impactful. Some of those were such big topics that they were covered over a series of stories. Looking back at 2018, here are their Top 10.