Helixgate https://validator.w3.org/feed/docs/rss2.html STAT+: Vertex kidney disease drug scrutinized for infection risk STAT+: Biopharma industry at odds over impact of Treasury’s new China rule STAT+: HHS green lights six peptides, despite concerns from FDA scientists STAT+: Pharmalittle: We’re reading about a new policy for compounding peptides, a PBM disclosure rule, and more STAT+: El-Sayed claps back at RFK Jr., and FDA’s ‘enforcement discretion’ on peptides Lilly’s Retatrutide Delivered Greater A1C Reduction and More Than Double the Weight Loss of Ozempic’s Highest Approved Dose in Head-to-Head Trial Alume Biosciences Announces U.S. FDA Breakthrough Therapy Designation Granted for Bevonescein, a First-in-Class Adjunct in the Real-Time Intraoperative Visualization of Nerves During Head and Neck Surgical Procedures in Adults HUTCHMED Announces Sovleplenib Granted US FDA Orphan Drug Designation for Primary Immune Thrombocytopenia Treasury’s proposed COINS rule could reshape NewCo deal terms Lilly’s tirzepatide juggernaut is still gathering momentum US gives $99m for Ebola jab project, as cases spread in Africa Dren Bio pockets $350m for rare blood cancer programme Flagship joins three biotechs together to form Etcelera 2026 report on biotech’s economic impact portrays a vast ecosystem IP: American as apple pie and essential for biotech BIO supports FDA’s new Fit-for-Purpose Rare Disease Framework Initiative Flagship blends three biotech startups to form Etcelera CDC report details impact of AMR pathogens HHS to allow compounders to make 6 unapproved peptides Genmab soars to record highs after cancer drug succeeds in key trial Research report: The Influence of Renal or Hepatic Impairment on the Pharmacokinetics of Iclepertin (BI 425809): Results from Two Phase I Open-Label, Non-randomised, Single Dose, Parallel Design Studies Stigmatizing language found in over half of primary care patient records LncRNA SBF2-AS1 Worsens Heart Injury After Attack via miR-149-5p/PHLPP2 Axis Biopharma cuts at manufacturing plants expected to affect 4,000+ HHS clears compounding pharmacies to manufacture 6 unapproved peptides Merck looks ahead to ‘another year of investment’ as Keytruda cliff looms What a cancer survivor sees that AI could miss in trial design Microbial Dark Matter Could Revive Antibiotics Decentralization, AI, and Gene Editing Are Opportunities for CGT Contractors Crossing the Digital Validation Chasm How the Heart Stays Strong with MCT1-Dependent Mitochondrial Lactate Import Three-Photon Microscopy Reveals Neural Activity Deep in the Mouse Brain Hamburg Hosts 2026 European Gene Therapy Conference Building the Future of AAV Gene Therapy Brain Quality Control Selectively Eliminates Neurons with Abnormal Variants in Development Stability, speed and strategy: Inside Australia’s early‑stage edge Ono cans 2 endocannabinoid drug studies after quintuple Phase 2 failure BMS drops Prothena-partnered neuro drug, sales outlook improves on a Q3 beat Dren Bio lands $350M to push rare blood cancer therapy toward market Quality and Regulatory Predictability: Shaping USP Standards – 12/11/2025 Search for Regulatory References | Drugs FDA Drug Info Rounds Video Frequently Requested or Proactively Posted Compliance Records Submit an eCTD v4.0 or Standardized Data Sample to the FDA Project Orbis Webinar for Stakeholder Engagement on the New Final Guideline on General Principles for Model-Informed Drug Development (ICH M15) – 10/29/2026 Drugs@FDA Data Files Newly Added Guidance Documents What’s New Related to Drugs Home