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Pfizer’s decision to cut its early-stage cancer asset was due to “strategic business reasons” and not driven by safety or efficacy concerns.
Of the 17 companies that were implored by the White House last July to apply Most Favored Nation pricing to their drugs, Regeneron is the last to agree—the same day the FDA greenlit its gene therapy for hearing loss in kids.
The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.
The takeover will give Amneal control of four facilities to manufacture biosimilars for a planned wave of launches in the coming years.
Chief Scientific Officer Pedro Beltran will succeed Eli Wallace as CEO of BridgeBio Oncology Therapeutics, as the board eyes a busy period of clinical advancement in the RAS oncology space.
Sanofi’s interim leadership sought on a Thursday earnings call to quell concerns that its sudden defense of Dupixent’s patents had anything to do with the departure of CEO Paul Hudson.
The FDA in July 2025 made publicly available over 200 complete response letters—an initiative that the investment community sees as “unanimously positive,” analysts told BioSpace.
Roche and Zealand Pharma announced last month that their amylin analog petrelintide elicited a 9% placebo-controlled weight reduction at 42 weeks—falling far below analyst and investor expectations.
This year’s American Academy of Neurology meeting included a presentation that could one day set a new treatment standard for myasthenia gravis.
The Durham plant will manufacture immunology, neuroscience and oncology drugs once AbbVie finishes construction in 2028.
In this episode of Denatured, you’ll be hearing from Dr. Sarah Howell, CEO at Arecor Therapeutics and Dr. Wendy S. Lane, clinical endocrinologist and diabetologist. We examine how increasingly connected and tailored diabetes technologies are reframing the field’s central opportunity around minimizing the day-to-day demands of managing the condition.
PRESS RELEASES
Source plant is widely regarded as one of the most valuable fragrance raw materials in the world Stage 2 contract follows successful Stage 1 completion in March 2026
Key Regulatory Benchmark Met, Differentiating DMX-101 from Traditional Opioid Analgesics Late-Breaking Results to be Presented at CPDD 2026 Annual Meeting
Live virtual fireside chat — investors, advisors, and life sciences analysts invited to attend Featuring Dermatologist Mary Spellman, M.D., with Phio CEO Robert Bitterman and Force Family Office CEO Steven Saltzstein
· First-in-class oral mechanism triggers natural satiety hormones, addressing key limitations of GLP-1 therapies · Phase I data demonstrate fat mass reduction, preservation of lean mass, 80% responder rate, and no serious adverse events