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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.
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While XEN1101 failed to hit the primary endpoint in a Phase II trial, the Canadian company is “actively exploring” further development of the program based on the totality of the data.
Pegozafermin showed statistically significant improvements in treating patients with nonalcoholic steatohepatitis, notching a win in the race to get the first treatment to market for the condition.
New data show the biologic significantly reduced exacerbations in chronic obstructive pulmonary disease, confirming positive results from an earlier trial.
A year after exiting the U.S. market, GSK is setting the stage for the antibody-drug conjugate’s possible return in relapsed/refractory multiple myeloma.
The biopharma company remains committed to its investigational BET inhibitor pelabresib after it failed to meet one of two key endpoints.
Advancements in asthma biologics spell future hope for patients with severe asthma.
After a negative review by an Independent Data Monitoring Committee, InDex Pharmaceuticals has decided to discontinue the late-stage CONCLUDE program evaluating its cobitolimod in ulcerative colitis.
Pfizer and BioNTech scored a win over Moderna on Tuesday as the European Patent Office decided that a key patent held by the Massachusetts biotech related to its COVID-19 vaccine is invalid.
J&J, AbbVie, Genmab and Genentech are presenting new data at next month’s American Society of Hematology meeting on the therapeutic potential of their therapies in multiple myeloma and mantle cell lymphoma.
CRISPR gene-editing has had its first ever approval in the UK. Will the FDA follow suit? What can patients expect the price tag to be?