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In this episode of Denatured, you’ll hear Philip Jacob Rosenfeld, professor of Ophthalmology at the University of Miami Health System and Bascom Palmer Eye Institute, and Wesley Jackson, chief science officer at Valitor. We talk about the eye condition call wet age-related macular degeneration (AMD), the limits of anti‑VEGF therapy and the push for true durability to change a patient’s life.
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BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
A growing number of biotechs are entering the market with newly launched medicines, a pattern indicative of “improving capital markets,” according to Jefferies’ Andrew Tsai.
Safety and access were top of mind at Monday’s public hearing exploring the regulation of psychedelic therapies. “The medicine opens the door,” NeuroAlchemy co-founder Michaela Vogt said during the meeting, but many other factors will ensure this new drug class can benefit patients.
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Newly solidified in their roles as the heads of CBER and CDER, Karim Mikhail and Michael Davis have been working for months to right the ship that had begun to capsize under former Commissioner Marty Makary. Meanwhile, Jared Seehafer will become the first-ever deputy commissioner focused on artificial intelligence.
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The TREM2 stabilizer failed to show efficacy in a Phase 2 trial of patients with early-stage ALS. This development follows two late-stage trial failures reported by Novartis last week, plus the news that the pharma has paused multiple CAR T cell trials following patient deaths.
Sling Therapeutics is advancing the first late-stage oral drug for thyroid eye disease that, if approved, could compete against Amgen and Viridian Therapeutics.
The FDA held a public forum on Monday to discuss the future of psychedelic therapeutics, followed by a meeting on Wednesday regarding recommendations for reauthorizing the Prescription Drug User Fee Act the day after launching its TrialBlazer initiative. Meanwhile, Definium Therapeutics notched another late-stage trial win for its LSD drug, and Novartis continues to reel from the company’s triple asset stumble.
The FDA aims to leverage the expertise of qualified research institutions paired with drug sponsors to lessen the risk of clinical holds during the investigational new drug review process and expedite the path to first-in-human development in the U.S. The initial application period will close on Oct. 30.
The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal years 2028–2032.
Analysts believe Cullinan Therapeutics and Taiho Oncology can overcome the safety risks as zipalertinib “sets [a] new bar” for first-line treatment of a type of lung cancer. The candidate is already under review for the the second-line setting, with a decision expected by early next year.
After inking a T cell engager pact with Chimagen Biosciences a few years ago, GSK is back for more, this time acquiring a multiple myeloma program from the antibody specialist.
GSK is consolidating its vaccine manufacturing operations to one site—located in Canada—amid the pharma’s recent $2.5 billion savings campaign.
Blood centers have the donors, resources and community footprint drug sponsors need to solve supply chain issues around cell and gene therapies.
After years of price pressures, the trade group argues “the economics of generics have deteriorated to the point where sustainability of the industry is in peril.”