Helixgate https://validator.w3.org/feed/docs/rss2.html Platelet Factor 4 (PF4) Radioimmunoassay Recall: Instrumentation Laboratories Removes HemosIL AcuStar HIT-IgG(PF4-H) FDA Approves Lucamzi (ranibizumab-blrz), a Biosimilar to Lucentis FDA Grants Accelerated Approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for Recurrent Respiratory Papillomatosis Hormone replacement therapy after cervical cancer treatment: a Japanese claims-based cohort study Hidden Peptides in Non-Coding RNAs Reshape Cardiovascular Biology One gene locus flags atrial fibrillation risk after major surgery, UK Biobank study finds Advancing Product Quality GDUFA III Changes for Facilities S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals FDA Rationale for Breakpoints Recognition Decision: Minocycline for Stenotrophomonas maltophilia Postmarketing Requirements and Commitments: Searchable Database New biotech Setara forms with $90M to take on Jazz’s bonus rare disease programs Sanofi targets late-phase and commercial M&A to offset looming Dupixent decline Aspen raises a $141M IPO in pursuit of a cell therapy for Parkinson’s Anthropic’s historic IPO; Akeso’s big clinical showing No Nonsense: David Liu Lauds Progress in Disease-Agnostic Gene Editing at ESGCT 100 Million-Cell AI-Ready Dataset with Single-Cell and Proteomic Data Created by Parse and Nomic Opentrons Raises $40M in Series E to Expand Its Robotics, Software, Data Infrastructure Genprex bets on a one-time gene therapy for diabetes (Part 3 of 3) Center for Drug Evaluation and Research Organization Chart GDUFA Paid Facilities List Notices of Updates Immutep, Molecular cut workforces STAT+: Vertex kidney disease drug scrutinized for infection risk Drugs@FDA Data Files What’s New Related to Drugs Newly Added Guidance Documents 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 Home