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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.
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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.
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.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
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Despite missing out on an FDA approval for major depressive disorder, Zurzuvae appears to be a strong asset for Sage Therapeutics, with high growth potential in 2024.
Eicos Sciences’ injectable vasodilator Aurlumyn is the first FDA-approved medication for severe frostbite to reduce the risk of finger or toe amputation by opening blood vessels and preventing clotting.
If you’re a researcher looking for your next challenge, check out these companies with current openings on BioSpace.
Changes to U.S. visa policy in 2022 reportedly increased the number of foreign-born STEM workers, but some say more needs to be done to ensure companies can hire the best talent.
The Federal Trade Commission and Department of Health and Human Services on Wednesday said they are investigating group purchasing organizations and drug wholesalers’ possible involvement.
This week, Greg, Heather and Tyler discuss reaction to Novo Nordisk’s purchase of Catalent and speculate on what that means for existing manufacturing contracts, customers and consequences with regulators.
The Department of Justice is seeking more information regarding Biogen’s overseas operations, while the Securities and Exchange Commission is looking into the launch of the now-defunct Alzheimer’s disease therapy Aduhelm.
Citing the need for more time to review additional Chemistry, Manufacturing and Controls information, the FDA has extended its target action date for Rocket Pharmaceuticals’ investigational gene therapy by three months.
Roivant Sciences will wind down operations for Hemavant, which was formed two years ago to advance RVT-2001 as a potential first-in-class treatment for transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes.
Approved in combination with three chemotherapies, Onivyde is the first new frontline treatment option in more than 10 years for adults living with metastatic pancreatic adenocarcinoma.