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FDA Commissioner Marty Makary intends to resign on Tuesday, according to several sources. This report follows a tumultuous 13-month tenure in which Makary oversaw the controversial rejections of several rare disease drugs and “predictable volatility” within the agency.
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New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
THE LATEST
The CEOs of J&J and Merck have finally committed to testifying before the Senate health committee regarding the high prices of drugs in the U.S. The hearing is set for Feb. 8.
The blockbuster immunotherapy secured separate late-stage victories as an adjuvant-setting treatment in renal cell carcinoma and muscle-invasive urothelial carcinoma.
The FDA’s myriad acronyms—and the differences between them—can be perplexing. BioSpace looks at the unique advantages of certain regulatory classifications for drug developers.
While the company expects sales growth to be flat this year, Lonza’s shares jumped around 14% Friday morning after reporting full-year 2023 sales of $7.75 billion, which was 3% above the consensus.
Late Thursday, ArriVent Biopharma announced its upsized initial public offering to support the development of its EGFR inhibitor furmonertinib, following CG Oncology going public earlier in the day.
While the FDA continues to investigate reported cases of T cell malignancies in patients who received CAR-T therapies, the cause of the secondary cancers remains unclear.
With the FDA’s approval on Thursday, Dupixent can now be used for the treatment of children aged 1 to 11 years who have eosinophilic esophagitis, a chronic disease that can severely impact their ability to eat.
Ahead of a Jan. 31 vote, Senate health committee chair Sen. Bernie Sanders on Thursday said he has the votes needed to subpoena the CEOs of Johnson & Johnson and Merck to testify on drug pricing.
Despite myriad stumbling blocks over the past two years, experts still see the potential of Bruton’s tyrosine kinase inhibitors to quiet progressive multiple sclerosis.
In the CONTACT-02 pivotal trial, the combination of Exelixis’ Cabometyx and Roche’s Tecentriq reduced the risk of disease progression or death by 35% in patients with metastatic castration-resistant prostate cancer.