FDA makes a rare threat over clinical trial results; appeals court upholds abortion pill restrictions

Taking stock of the drug industry, from the lab to the medicine chest

August 16, 2023 Check out STAT+

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By Ed Silverman Pharmalot Columnist, Senior Writer

Molly Ferguson for STAT STAT+ | In a rare move, FDA threatens to fine a company for failing to report clinical trial results Thousands of clinical trial results are still missing in violation of the law, said Till Bruckner of the TranspariMED advocacy group. By Ed Silverman Appeals court upholds limits to abortion pill A federal appeals court on Wednesday ruled to restrict access to the abortion pill mifepristone but not remove it from the market entirely. By Sarah Owermohle STAT+ | FDA approves first treatment for ultra-rare bone disease The treatment, an oral medication, faced some questions about the quality of its data, and was rejected by European regulators. By Andrew Joseph and Damian Garde Courtesy Secrist family STAT+ | With an age cutoff for a new gene therapy, families and doctors scramble to treat kids before their 6th birthday Sarepta's Elevidys has been approved for a narrow age range of boys with muscular dystrophy — excruciating for boys who are a hair too old. By Jason Mast The latest recall of Philips ventilators reveals one death, two injuries Philips has recalled ventilators that absorbed dust and dirt into breathing tubes. The FDA said one death is associated with the issue. By Lizzy Lawrence Why drug shortages are having an outsize impact on ovarian cancer patients Ovarian cancer is relatively common, and the platinum-based drugs most effective in treating it are the ones in short supply. By Annalisa Merelli

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