Helixgate https://validator.w3.org/feed/docs/rss2.html 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 Cure HHT wins inaugural Prix Galien Patient First Award Automated platform optimizes enzyme production using cell-free protein synthesis and AI-driven design A CRISPR gene boost reduces seizures and strengthens muscles in mice RNA-protein interactions could lead to new coronavirus drug targets Breaking the silos: What effective scenario modeling looks like in 2026 and beyond Earnings roundup: AstraZeneca’s cost cuts, Alnylam’s slump and Regeneron’s resilience Karyopharm, deep in debt, to sell itself in bankruptcy Teva’s pipeline in 2027: Can it sustain its transformation?  Plug-and-play gene therapy: FDA executes on vision that’s been in the works for years UniQure snags May Day decision date for Huntington’s gene therapy after arduous year Cell therapy investment grows as safety events rankle Big Pharma’s CAR T autoimmune push FDA peptide policy risks undermining drug development and patient safety BridgeBio gears up for rare muscular dystrophy launch with FDA approval in sight Drugmakers rush to pair up with Summit’s ivonescimab ahead of key verdict Significant stock movers of October: Biohaven climbs, ArriVent dives Tiziana touts multiple sclerosis win at lower dose as high dose misses mark Home