Helixgate https://validator.w3.org/feed/docs/rss2.html Editor’s Pick: Wild Bioscience Q3 earnings roll on, FDA pushes rare disease, uniQure’s Huntington’s therapy reaches review Sanofi’s axing of Nurix STAT6 program ‘not a target-related issue’ Amgen starts MariTide autoinjector study as pivotal readouts approach AbbVie bets up to $1.47B for Nxera’s discarded IBD program 2026 IPO stock tracker: How newly public biotechs are performing EVERSANA builds its AI Agency with Estima acquisition Case study backs YolTech’s AATD gene therapy German sites added to Europe’s cardiometabolic R&D network Karyopharm files for bankruptcy, looks to merger with Ayrmid for life raft Pfizer flat in Q3 despite 32% growth for new and acquired products Neurocrine defends Prader-Willi drug after another patient death Lonza agrees to buy 5 Merck KGaA facilities to accelerate US expansion Compass to submit psilocybin depression drug for approval imminently after stock wobbles Pfizer, fresh to China’s obesity market, looks to Viagra model to compete 6 potential blockbusters that could pave China’s path to 2030 ambitions Importing Drugs with a Pre-Launch Activities Importation Request (PLAIR) Questions and Answers on Current Good Manufacturing Practice Regulations | Production and Process Controls Advancing Generic Drug Development: Bioequivalence Challenges for Patient-Centric Oral Formulations – 06/11/2026 How to Register a Drug Establishment What’s New in Regulatory Science Top biotech deals in October 2026  Why global expansion is changing the shape of the ATMP supply chain UniQure gets an FDA decision date; Teva scraps brain drug study Medicare Part D premiums are spiking 50% on average next year, KFF finds Vertex, ahead of FDA decision, calms fears surrounding kidney drug FDA commissioner: CEO or policy wonk? Pharma a safe haven from an AI crash? Missed endpoints, futility findings drive string of CNS discontinuations Astellas takes option on Audax’s IL-12 program: Deals Report FDA approves plasmid DNA-based immunotherapy for rare viral disease STAT+: Servier’s $1.55 billion muscular dystrophy drug fails first major test FDA Delays PDUFA Action on Agios’ Mitapivat sNDA for SCD Sentira Brings Claude’s AI to 10x Genomics’ Chromium Platform FDA Sets May 1 PDUFA Action Date for uniQure’s Huntington’s Disease Gene Therapy Recursion Eyes H2 2027 Pivotal Trial for Lead Candidate After Positive Phase II FAP Data Untitled Letters GDUFA Paid Facilities List Prescription Drug User Fee Amendments STAT+: FDA OKs generic HIV prevention shot, widening access for lower-income countries STAT+: Who will get the first psychedelic approved? STAT+: Pharmalittle: We’re reading about a generic HIV prevention shot, Lonza buying U.S. facilities, and more FDA Rare Disease Innovation Hub PACE panel lays out patient input possibilities in PDUFA VIII FDA Advises Consumers Not to Buy or Serve Once Upon a Farm Tractor Wheels Organic Toddler Soft-Baked Bars Inovio stock rises 2.5-fold on plasmid DNA drug approval Fresenius doubles down on biosimilars with big WuXi alliance Hutchmed, AZ file Orpathys for lung cancer on ESMO data Ultragenyx gets first Euro nod for rare disease drug Dojolvi Home