Helixgate https://validator.w3.org/feed/docs/rss2.html Longeveron’s phase 2b stem cell flop spurs cost cutting, exploration of ‘all options’ Goa Therapeutics launches with ‘immeasurably huge’ vision of creating Narcan for alcohol After one failed acquisition attempt, Lisata finds lifeline in Marea merger Roche signs $1B deal with Dualitas to pair up on big bispecific screening drive North Immunology goes public via reverse merger as eczema drug heads toward clinic Xenon pauses phase 3 depression trials after psychosis events BMS dumps $100M Orum degrader-antibody conjugate after glimpsing phase 1 data Inflammation biotech Electra charges up with $350M from upsized IPO Chutes & Ladders—Legend poaches Novartis vet to boost commercial potential Boehringer launches hub for patient experience data STAT+: A biotech hedge fund births a new immunology company  STAT+: A Sellas immunotherapy study, long delayed, will end in failure STAT+: FDA approves a new gene therapy for Sanfilippo syndrome, an ultra-rare disease Bayer’s Kerendia (finerenone) Receives FDA Approval as the First New Treatment in 30 Years for Adults with Chronic Kidney Disease (CKD) and Type 1 Diabetes FDA Approves Fayuvi (rebisufligene etisparvovec-hopf) Gene Therapy for the Treatment for Sanfilippo Syndrome Type A (MPS IIIA) Viatris’ Wakix receives Japanese approval to treat OSAS and narcolepsy Cellares and GenomeFrontier to assess automated GF-CART01 production Novo’s Denecimig Demonstrates Tolerability After Switch from Emicizumab in FRONTIER5 Study of People with Haemophilia A as Published in the Journal of Thrombosis and Haemostasis Roche bets up to $1B to advance next-gen bispecifics with Dualitas Longeveron’s shares crash as stem cell therapy flunks mid-stage cardio trial After Novartis’ devastating M&A losses, long live the executive willing to try Webinar: Manufacturing in Turbulent Times Novo notches up to $1.4B pact with Orbis to develop oral macrocycle cardiometabolic drugs C3TI Compass (Knowledge Repository) Reporting Prescription Drug Sample Losses, Known Thefts, and Possible Diversion in the Aftermath of a Natural Disaster FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize January – March 2026 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS) Human Drug Compounding Drug Safety Oversight Board (DSB) Meeting June 26, 2024 FDA Public Workshop: Future Needs for the Development of Interchangeable Products – 09/19/2025 Verified Clinical Benefit | Cancer Accelerated Approvals Korea Filler Experts – 718706 – 11/03/2025 Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act Animal Rule Information Jobs in Oncology/Hematology 8 biotech IPO prospects testing investor appetite Sling banks $123M for an experimental thyroid eye disease pill STAT+: Pharmalittle: We’re reading about faster FDA approvals, access to experimental drugs in Montana, and more STAT+: The FDA’s rebuilding effort is running into a new challenge STAT+: England to cover AstraZeneca breast cancer drug, a result of U.K.-U.S. drug pricing deal STAT+: FDA has too few staffers to hire more staff STAT+: Pharmalittle: We’re reading about FDA hiring delays, a new Bavarian Nordic CEO, and more Ongoing | Cancer Accelerated Approvals Sleep deals cluster in narcolepsy and sleep apnea SK pens $315M pact with fellow South Korean company for Parkinson’s prospect Science Spotlight: A macrophage-recruiting bispecific, plus new tactics against TCR-T escape and tumor stroma Oncology biotech news: key moves to watch in September 2026  Legend Biotech names Novartis veteran Ingrid Zhang as new CEO Ori locks down $120M pact to deploy automated production platform for unnamed commercial cell therapy Home