News
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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Women are often at the forefront of innovation, making up nearly half of the life sciences industry despite a shrinking but persistent wage gap. Inceptor Bio is at the forefront of closing inequality.
If biopharma-focused co-working spaces continue to catch on, they could expand job opportunities for those outside of the typical hot spots.
BioMarin announced Tuesday that the FDA has accepted its supplemental New Drug Application to expand Voxzogo for children younger than five years with achondroplasia.
Volastra Therapeutics has in-licensed Amgen’s sovilnesib, a KIF18A inhibitor being studied for high-grade ovarian cancer, triple-negative breast cancer and other solid tumors.
BridgeBio posted data Monday from its small but highly anticipated Phase II study of infigratinib in achondroplasia - a drug that could give BioMarin a run for its money.
Merck presented Phase IIb data at ACC Monday showing that its hypercholesterolemia hopeful met the primary endpoint.
Moderna may seek the FDA’s accelerated approval for its personalized cancer vaccine, president Stephen Hoge said Monday.
The FDA set a decision date of July 6, 2023 for Eisai and Biogen’s recently approved Alzheimer’s drug, Leqembi, Eisai announced Monday.
With the results from the CLEAR outcomes study, Esperion is poised for a major inflection in sales and is targeting blockbuster status, said CEO Sheldon Koenig on an investor call Monday.
Here are some tips to help you nail virtual interviews and networking events so you can be prepared for BioSpace’s Virtual Talent Connect on March 9.