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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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Read our takes on the biggest stories happening in the industry.
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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Months after the FDA lifted its partial hold on their Phase II multiple myeloma program, Kite and Arcellx are expanding their existing development and commercialization collaboration in the blood cancer space.
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On the heels of cutting 100 jobs in Ireland, Pfizer is laying off around 500 workers from its Sandwich, Kent facility in the U.K. under its cost-reduction plan to save $3.5 billion through 2024.
Whistleblowers allege that ZZ Biotech co-founder Berislav Zlokovic pressured his scientists to adjust data in favor of the investigational stroke therapy 3K3A-APC, according to a dossier obtained by Science.
In this episode BioSpace’s Greg Slabodkin, Tyler Patchen and Lori Ellis discuss Zepbound, Wegovy, the weight loss race and the future of this drug class.
Watch this webinar to gain insights from expert speakers, Dr. Iris Alroy and Dr. Kristopher Brannan, who have made significant advancements in the field of RBPs.
Executives from Israel-based companies express concern about future investment and other operational impacts, as the war rages on in Gaza with tragic loss of life amid political and economic uncertainties.
In today’s challenging environment, here are some creative ways biotechs have found to survive and thrive.
Under the potential $770.5 million deal announced Tuesday, Autifony Therapeutics is licensing to Jazz Pharmaceuticals two ion channel targets associated with neurological disorders.
When given with chemoradiotherapy, Imfinzi in a late-stage non-small cell lung cancer study did not lead to significant improvements in progression-free survival versus chemoradiotherapy alone.