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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
Topline data from the Phase III NATALEE study showed Novartis’ Kisqali met its primary endpoint, reducing the risk of recurrence in early breast cancer.
The FDA approved Pharming’s leniolisib, now to be marketed as Joenja, for the treatment of the ultra-rare disease-activated phosphoinositide 3-kinase delta syndrome, the company announced Friday.
The FDA has granted an advisory committee meeting for BrainStorm Cell Therapeutics’ investigational ALS therapy, NurOwn, the company announced Monday.
Relmada Therapeutics announced it would make key changes to its clinical evaluation of REL-1017 as a possible add-on treatment for major depressive disorder.
The FDA is expected to make decisions on Emergent BioSolutions’ sNDA for OTC Narcan and Roche’s Polivy in frontline DLBCL.
Upstaza is the first targeted therapy for aromatic L-amino acid decarboxylase (AADC) deficiency. PTC expects to submit a Biologics License Application to the FDA in the first half of 2023.
Analysts point to a missed secondary endpoint and cardiovascular risks that may delay FDA approval as possible reasons for the unexpected drop in Karuna’s stock following the data reveal.
In a double data drop Thursday, AbbVie touted two clinical trial wins, for Skyrizi in ulcerative colitis and Rinvoq in systemic lupus erythematosus.
Wednesday, the FDA approved Cidara Therapeutics and Melinta Therapeutics’ Rezzayo (rezafungin) injection to treat candidemia and invasive candidiasis.
Ageism, or discrimination against an individual based on their age, is a common barrier many older individuals face in the workplace. Fortunately, there are steps that can be taken to mitigate this discrimination.