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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The lynchpin to biotech and pharmaceutical drug development in the United States is arguably the greater Boston area, which includes the white hot square mile of talent and intellectual collaboration found in Kendall Square.
EMD Serono, a unit of Merck KGaA, Darmstadt, Germany, announced that the U.S. Food and Drug Administration (FDA) had approved Mavenclad (cladribine) for adults with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive disease (SPMS).
There are three companies looking for decisions by the U.S. Food and Drug Administration (FDA) this week. All three drugs are either resubmissions or have had to deal with various problems related to manufacturing or incomplete data. Here’s a look.
Cambridge, Mass.-based Sarepta Therapeutics announced data from its interim analysis of muscle biopsy endpoints of its therapy casimersen for Duchenne muscular dystrophy (DMD). The interim data was strong enough to support a probable New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) by mid-year.
Gottlieb said the FDA believes there should be a premarket demonstration that a new opioid is superior to an already-approved opioid.
Novartis will quickly roll Mayzent out to U.S. physicians. The Swiss pharma giant plans to make the drug available within one week of the FDA approval.
Shares of Jazz Pharmaceuticals are climbing in premarket trading following a late Wednesday announcement that the U.S. Food and Drug Administration granted approval for Sunosi, a treatment for people with narcolepsy.
Hitachi Chemical Diagnostics, Inc., a global leader in multiplex allergy in vitro diagnostics, announced today that it received 510 clearance from the U.S Food and Drug Administration for its new high capacity allergy testing instrument, OPTIGEN® AP 3600TM.
The approval of Zulresso marks the first and only treatment for postpartum depression (PPD) approved by the U.S. Food and Drug Administration.
This approval marks the first new initial treatment option for this difficult-to-treat type of lung cancer in more than 20 years.