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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Teva and Mylan are looking over their shoulders this morning after the FDA gave Novartis and Momenta the green light for their Copaxone copycat drug.
The FDA approved Vertex’s Symdeko for cystic fibrosis in patients ages 12 and older with two copies of the F508del mutation.
The FDA approved Gilead’s triple combination treatment for HIV, Biktarvy.
Topcon’s touted its system as being able to quickly penetrate ocular tissues without being obscured by hemorrhage or media opacities.
Ra Medical only has five full-time salespeople on staff, but expects that to grow to 20 to 25 people later this year.
The company believes the Translarna data is compelling and pointed to the success the drug is having in Europe.
2017 was the second-best year for FDA approvals since 1996.
The FDA approved Merck’s and Pfizer’s Steglatro, a SGLT2-inhibitor, that will square off against established drugs in the market.
The FDA broke new ground today with a first-of-its-kind therapy for eye disease.
Christmas came a week early for Aerie Pharmaceuticals.