Helixgate https://validator.w3.org/feed/docs/rss2.html 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 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 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 Sun Pharma stops eye-care drug production at Indian plant amid quality issues STAT+: Coming readout of Kymera eczema trial is a high-stakes moment in a bid to rival Dupixent STAT+: Psilocybin’s lasting benefits prove elusive in mice Vistagen cuts workforce for second time in 2026 FDA Approves First Once-Weekly Insulin for Type 2 Diabetes Mellitus in Pediatric Patients How can biopharma overcome digital transformation failure? StockWatch: Gene Editing Shares Jump on ESGCT Data, FDA Draft Guidance Acumen Pharmaceuticals Announces Topline Results from Phase 2 ALTITUDE-AD Clinical Trial of Sabirnetug (ACU193) for the Treatment of Early Alzheimer’s Disease; Trial Did Not Meet Primary Endpoint Pathos AI completes $237m Series E round to expand oncology pipeline Lunit and Summit to evaluate pathology platform for tumour analysis China’s NMPA accepts Innovent application for sintilimab combo Regeneron agrees to $270m extension to supply Ebola medicine in US Arrowhead gains UK marketing authorisation for Redemplo FDA grants orphan drug status to Octant’s OCT-980 for RP Co-co deals may be one casualty of the COINS Act for U.S. biotechs Tallying equity in NewCo deals as COINS raises the stakes Juvia, Lightspeed lead Dren’s $350M round as oncology program advances: Venture Report The impact of Gilde’s Impact Council with Joep Muijrers  What made Estuary’s kidney gene therapy bet investable Auchincloss bill seeks to improve ‘operating system for science’ Home