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Heath Secretary Robert F. Kennedy Jr.’s efforts to overhaul vaccine policy are likely illegal, a Massachusetts District Court Judge ruled; Structure’s GLP-1 weight loss pill succeeds in Phase 2 while Rhythm’s Phase 3 basket trial fails to find the beat; Eli Lilly warns of potential safety risks of taking compounded tirzepatide, and Novo Nordisk is hit with an FDA warning letter regarding adverse events potentially linked to Ozempic.

Incyte is looking to expand the use of its PD-1 blocker Zynyz to treat non-small cell lung cancer. The FDA’s rejection did not flag problems with the drug’s efficacy or safety.

With the approval of Wegovy HD, Novo Nordisk joins Johnson & Johnson, Boehringer Ingelheim and USAntibiotics as beneficiaries of the FDA’s Commissioner’s National Priority Voucher program, which aims to review products that align with certain national priorities in less than two months.

Gilead continues its dealmaking spree in the sizzling hot space of I&I as Johnson & Johnson, along with partner Protagonist, notched an FDA approval for a new psoriasis drug. Plus, Aurinia Pharmaceuticals gets a new C-suite, FDA releases draft guidance on non-animal models and the CDC’s vaccine advisory committee is not being disbanded after all.

With thousands of companies and a $102 billion impact on the state’s economy, Indiana’s life sciences industry is making its mark. The president and CEO of the Indiana Life Sciences Association discusses the sector’s upside, challenges and where it’s headed in the future.

Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.

UniQure and REGENXBIO are both dealing with FDA setbacks for their respective gene therapies, as regulatory experts question the FDA’s decision-making processes; CBER director Vinay Prasad is under probe for allegedly fostering a toxic workplace; Sarepta CEO Doug Ingram is stepping down after several years of tumult at the top of the muscular dystrophy–focused company; and Eli Lilly again tops Novo Nordisk in a weight loss trial.

A Massachusetts judge called Kennedy’s efforts to reform the CDC’s vaccines advisory panel a “procedural failure,” adding that the new committee members do not “comport with governing law.”

FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.

Zealand Pharma’s shares fell 32% in early morning trading Friday after its Roche-partnered asset petrelintide failed to meet investor expectations in a mid-stage clinical trial.