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The resubmission for RGX-121, expected in the third quarter, comes as the FDA has deemed REGENXBIO’s existing data “sufficient” to support an accelerated filing. It immediately follows a similar reversal of position regarding uniQure’s embattled Huntington’s disease gene therapy.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.
UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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FDA inspectors found that Medline, which raised billions of dollars last year, failed to prevent repeat bacterial contamination of finished drug products.
Revolution Medicines stole the show at the 2026 American Society of Clinical Oncology meeting as full data from its pancreatic cancer drug lived up to expectations, while Summit and Akeso proved the PD-(L)1/VEGF mechanism and Eli Lilly showed that its in vivo CAR T bet is paying off.
NewLimit is pressing the gas, speeding into clinical trials much sooner than expected after lab research showed its epigenetic reprogramming asset reversed aging in human liver cells.
Celcuity’s gedatolisib doubled progression-free survival versus standard of care in certain patients with advanced breast cancer. Still, the biotech’s stock dropped more than 25% Tuesday.
Travere Therapeutics will gain an exclusive license to the oral BTK inhibitor civorebrutinib, which analysts at Guggenheim Securities said could be “complementary” to the biotech’s IgA nephropathy drug Filspari.
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency.
All six non-Hodgkin lymphoma patients on Legend Biotech’s CAR T therapy responded to treatment—findings that could make the biotech an attractive takeover target, according to analysts at Oppenheimer.
For an investment of up to $1.9 billion, Eli Lilly will be able to use Ascidian Therapeutics’ platform that removes mutated exons from mRNA molecules, avoiding the expression of disease-causing proteins.
Improved survival on display at the American Society of Clinical Oncology (ASCO) in Chicago; Pfizer’s unusual pact with China’s Innovent highlights a new type of collaboration; Eli Lilly continues its nonstop deal streak, including with Chinese biotechs; and looking ahead to this weekend’s American Diabetes Association meeting.