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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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Loqtorzi is the first programmed death receptor-1 from China to be approved by the U.S. regulator, and the first for patients with recurrent or metastatic nasopharyngeal carcinoma across all lines of treatment.
In a briefing document for Tuesday’s advisory committee meeting, the FDA raised concerns about the potential off-target effects of Vertex Pharmaceuticals and CRISPR Therapeutics’ investigational gene edited therapy.
The Japanese pharma’s attention deficit/hyperactivity disorder candidate has shown significant symptom improvements in children and adolescents in two late-stage studies.
Merck and Novartis beat expectations this week with solid third-quarter financial results, while BMS, Sanofi and Takeda spooked investors with negative near- and mid-term projections.
The French drugmaker’s shares dropped more than 15% Friday morning on the announcement that it has abandoned its goal of a 32% operating profit margin for 2025, focusing on long-term profitability.
Following an FDA rejection and a previous discontinuation in psoriasis, Eli Lilly’s anti-IL-23 antibody has finally won an approval in ulcerative colitis, joining a crowded inflammatory bowel disease market.
The company’s blockbuster cancer asset Keytruda brought in more than $6.3 billion in the third quarter, a 17% increase from the same period last year, while bolstering its antibody-drug conjugate portfolio.
Santhera Pharmaceuticals and partner Catalyst Pharmaceuticals got the FDA’s greenlight for their Duchenne muscular dystrophy drug Agamree, which is expected to launch in the first quarter of 2024.
The company on Thursday said it now expects more than $10 billion in new product sales in 2026, despite previously forecasting $10 billion to $13 billion in 2025.
With recent high-profile failures, experts say safety concerns and a lack of diversification are hindering the field—but still hold out hope for an approval.