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The FDA’s extension will give reviewers more time to review a major amendment to Biogen and Eisai’s application for a subcutaneous induction formulation of Alzheimer’s therapy Leqembi. The new target action date is on Aug. 24.
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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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With robust sales performance from oncology darling Darzalex and immunology superstar Tremfya, Johnson & Johnson is “off to a fast start in 2026,” CEO Joaquin Duato told investors on Tuesday.
With many overseas patients preferring orals to injectables, Eli Lilly has filed for approval of orforglipron in more than 40 countries and is building manufacturing capacity to support the obesity drug.
Eli Lilly is putting its obesity windfall to work again, striking a new deal to acquire CrossBridge Bio, a small Texas biotech known for its cancer tech.
During the pharma earnings season, which begins on Tuesday, Novo Nordisk will report the first revenue numbers from an oral GLP-1 medicine, while other companies are expected to address the FDA, drug pricing and Trump’s new tariffs.
The FDA has greenlit Travere Therapeutics’ Filspari as the only available treatment for focal segmental glomerulosclerosis despite the drug’s loss to Sanofi’s Avapro in a Phase 3 study.