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FDA
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.
FEATURED STORIES
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.
ALS
Biogen’s Qalsody won FDA approval in 2023 to treat a rare, genetic form of amyotrophic lateral sclerosis. On Tuesday, QurAlis presented interim Phase 2 data showing the potential of a similar drug to more broadly treat the neurodegenerative disease.
As Q1 earnings arrive, three biotechs have big quarters ahead, with two—Amylyx and Neumora Therapeutics—betting at least partly on novel assets for obesity.
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The company is establishing commercial production capabilities to fuel plans to launch autologous CAR T cell therapies in China.
FDA
Sarepta Therapeutics says the FDA has agreed to review a regulatory package for Amondys 45 and Vyondys 53 after they failed a confirmatory trial, but whether the agency will agree to approve them is still unknown.
Eli Lilly’s retatrutide could present a “differentiated option” for patients with type 2 diabetes who want to control their blood sugar and achieve maximal weight loss, according to analysts at BMO Capital Markets.
Gossamer Bio reported last month that its only late-stage candidate failed a Phase 3 study in pulmonary arterial hypertension, casting doubt on the asset’s future prospects.
Prime biotech buyout targets such as Revolution Medicines and Ascendis Pharma have recently found themselves in the middle of acquisition rumors—though no deals have panned out so far.
In this episode of Denatured, you’ll listen to Viswa Colluru, CEO and founder of Enveda and Akshay Rai, principal, Healthcare & Biotech Investments at Premji Invest. We speak about how AI platforms must now prove themselves through proprietary data, focused pipelines and clinical readouts in competitive diseases to garner investor interest.
Among those who connected salary increases to swapping out employers, 75% saw pay rise by at least 6%, and the most often cited increase was 10%, according to the just-released BioSpace salary report.
Recruiters can play a significant role in biopharma professionals getting hired, especially in an employer-driven job market. However, when working with them, candidates need to avoid making six key mistakes, from waiting too long to ask for help to prematurely contacting hiring companies.
BioSpace‘s 2026 U.S. Life Sciences Salary Report delivers a comprehensive look at how salaries, bonuses and benefits evolved over the past year amid ongoing economic pressure and workforce recalibration. It uncovers not just what people are earning, but how they’re thinking about compensation, career moves and total rewards in 2026.
As Congress debates renewing the Act for ALS, it must prepare for the coming era of precision ALS medicine by prioritizing early-stage research to more quickly bring effective treatments to the market.