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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Has the U.S. Food and Drug Administration failed to do its due diligence in finding and reporting financial conflicts of interest between members of its scientific advisory committees and pharmaceutical companies?
Merz Neurosciences announced that the U.S. Food and Drug Administration approved a treatment for chronic drooling in adults.
Shares of Alkermes plc are climbing in premarket trading after the company announced the U.S. Food and Drug Administration approved Aristada Initio (aripiprazole lauroxil) as part of a combination treatment for schizophrenia.
Shares of Menlo Park, Calif.-based Dermira jumped more than 10 percent this morning after the U.S. Food and Drug Administration (FDA) approved its therapy for people who have excessive underarm sweating.
After failing to gain market share under the umbrella of Valeant Pharmaceuticals, Addyi is getting a relaunch at half the price.
Array BioPharma, Inc. secured approval for its combination treatment for BRAF-mutant metastatic melanoma.
Pain Therapeutics stock plunged 70 percent after a U.S. Food and Drug Administration (FDA) advisory committee voted 14 to 3 against approval of its Remoxy ER for severe pain.
Shares of Achaogen are down more than 19 percent in early trading after the FDA handed down a split approval and rejection of Zemdri (plazomicin) for the treatment of complicated urinary tract infections and bloodstream infection, respectively.
The FDA accepted Genentech’s New Drug Application (NDA) for baloxavir marboxil, a single-dose, oral flu treatment for people 12 years and older. It also granted it Priority Review.
In a first of its kind ruling, the U.S. Food and Drug Administration approved GW Pharmaceuticals’ Epidiolex, a cannabis-based treatment for seizures associated with two rare forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome.