Helixgate https://validator.w3.org/feed/docs/rss2.html Arrowhead’s Ionis problem, Kyverna’s next-gen end and more biotech earnings PharmaLogic buys Lantheus plant to build transatlantic radiopharmaceutical CDMO Cellectis could cut 70% of workforce in shift to in vivo therapies FDA approves durvalumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer Section 804 Importation Program Policies and Authorizations FDA Approves First Drug to Treat Adults with Primary Membranous Nephropathy Cancer vaccine development gets complicated From hope to adoption: an industry perspective on the maturation of new approach methodologies Immunogenicity risk assessment of novel modalities using new approach methodologies Regeneron’s POTS antibody curbs heart rate spikes, teeing up Phase 3 trial Windward nets $175M IPO, bringing 2026 biotech debuts to 35 Windward prices IPO, Rezera postpones its offering: Finance Report China’s innovation moment sees a rise in first in class BIO’s plan for ‘securing America’s biotech century’ Medline Updates Customers and Patients on Repair and Replace Program for Recall of Medline Brand Beds, Rails, Mattresses and Accessories Inside Arbor’s CNS pipeline and next-generation gene editing STAT+: Oura’s acquisition of health tech startup raises conflict-of-interest questions for Eli Lilly, experts say STAT+: Pharmalittle: We’re reading about Lilly conflict questions, a DEA OK for a narcolepsy pill, and more STAT+: HHS plans funding for research into ibogaine for PTSD What’s New Related to Drugs Notable Approvals | Drugs How Nasdaq became biotech’s default exchange — and why the IPO comeback is testing its value Overton’s iffy FDA confirmation; a slashed US IPO Reference Genomes of Malaria-Causing Plasmodium Parasites Completed Downstream Processing: Purifying Complex Antibody Therapeutics When Target Molecules Misbehave Oncology (Cancer)/Hematologic Malignancies Approval Notifications Blackstone bets $1.5B on Pfizer’s obesity drug Windward prices $175M IPO to advance China-licensed lung drugs This week in charts: Brain drugs are back on venture capitalists’ minds Novo submits sickle cell drug; Flagship, Gates Foundation deepen ties BMS shakes up R&D under CMO Cristian Massacesi Microsoft outage disrupting healthcare; reports Neurosterix’ $105m round leads the week’s biotech financings Rapid DEA review clears way for Takeda’s narcolepsy launch Windward Bio catches $175m from its IPO Milestone cutting 20% of HQ team, including CMO GDUFA Paid Facilities List How can gene therapy platforms be scaled up to treat thousands of rare diseases? Drugs@FDA Data Files STAT+: What to know about Biogen’s big lupus study readout White House push puts Overton back in play ahead of Nov. 18 HELP vote Keveney stepping away from role as FDA’s chief counsel Applications for logic gating expand at SITC 2026 Growing neoantigen vaccine pipeline tests the modality’s reach A comprehensive analysis of CBER experience with AAV gene therapy IND submissions Biopharma layoffs rise YOY in October but sharply trend down for 2026 2026 Q3 Job Market Report: Job opportunities, layoffs show YOY improvement Pfizer snags $1.5B financing from PE firm Blackstone to support Metsera asset FDA’s commissioner voucher program reportedly shuttered ahead of Senate vote on Overton Home