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868 stories matching this filter · ← front page

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  • Merck KGaA to acquire Silence Therapeutics for $1.3 billion, adding Phase-2 RNAi drug for polycythemia vera
    Merck KGaA announced it will purchase UK‑based Silence Therapeutics for about $1.3 billion, paying $20 in cash per share, representing a 130 % premium. The deal gives Merck control of an RNA‑inter…
    BioPharma Dive · 25d agoDealPositive↗ source
  • Disc Medicine reports positive Phase 3 results for bitopertin in erythropoietic porphyria
    Disc Medicine announced that its experimental therapy bitopertin achieved its primary and secondary goals in a Phase 3 trial for erythropoietic porphyria, a rare condition that makes patients extre…
    BioPharma Dive · 25d agoPositive readoutPositive↗ source
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Ophthalmology1079
Endocrinology & Metabolism785
Pain784
Nephrology764
  • Saudi Arabia rolls out biotech partnerships to support its $34.6 billion non‑oil growth plan
    Saudi Arabia’s National Biotechnology Strategy, launched in early 2024, aims to add $34.6 billion to non‑oil GDP by 2040 and create 11,000 jobs by 2030. The plan is now moving beyond policy into co…
    BioPharma Dive · 25d agoPositive↗ source
  • Early CDMO engagement: balancing speed with flexibility in CMC planning
    Bringing a new therapy to the clinic requires clinical, non‑clinical, regulatory and CMC activities to move forward together. In early development, having drug material available is often on the cr…
    BioPharma Dive · 25d agoNeutral↗ source
  • Philips issues updated use instructions for Lumify ultrasound systems after software glitch risk
    Philips Ultrasound has sent a letter to customers of its Lumify diagnostic ultrasound system, advising that the devices require updated use instructions. The update addresses a software applicatio…
    fda medwatch · 25d agoCRLNegative↗ source
  • Study shows low extractables in single-use components support ADC manufacturing
    Cytiva conducted extractables testing on disposable chromatography column housings and flow kits used in antibody-drug conjugate production. The tests used dimethylacetamide (DMA) and dimethyl sul…
    BioPharma Dive · 25d agoNeutral↗ source
  • Moderna’s stock soars after Phase 3 success of melanoma vaccine with Merck
    BioPharma Dive’s latest data-visualization series charts Moderna’s dramatic stock rebound in 2026 after a period of decline. The company had struggled when demand for its COVID-19 vaccine fell, pr…
    BioPharma Dive · 28d agoPositive readoutPositive↗ source
  • Iambic Therapeutics CEO discusses $150 million IPO and AI's evolving role in drug development
    Iambic Therapeutics completed a $150 million initial public offering, raising fresh capital and seeing its share price climb to about $24.50, roughly a 50% increase from earlier in the week. CEO T…
    BioPharma Dive · 28d agoDealPositive↗ source
  • City Therapeutics raises $200 million in IPO to fund next-gen RNAi programs
    City Therapeutics, a biotech focused on RNA interference, completed a $200 million initial public offering, selling about 11.1 million shares at $18 each. The proceeds will back three drug candida…
    BioPharma Dive · 28d agoDealPositive↗ source
  • Estuary Biotherapeutics raises $93 million Series A to develop gene therapies for ADPKD
    Estuary Biotherapeutics, a California gene‑therapy startup backed by Biogen, announced a $93 million Series A financing led by RA Capital. The capital will support development of two genetic medic…
    BioPharma Dive · 28d agoDealPositive↗ source
  • FDA launches Rare Disease Framework Initiative to overhaul review process
    The FDA announced a new Rare Disease Framework Initiative aimed at redesigning how therapies for rare conditions are regulated. The initiative will move away from a one-size-fits-all model, instea…
    BioPharma Dive · 29d agoRegulatoryPositive↗ source
  • Iambic Therapeutics raises $150 million in IPO, begins Nasdaq trading under ticker IAM
    Iambic Therapeutics, an AI-driven drug discovery startup, completed an initial public offering that raised $150 million. The company sold about 9.4 million shares at $16 each and will start tradin…
    BioPharma Dive · 29d agoDealPositive↗ source
  • Belgian startup Armed Cell Therapeutics acquires Galapagos-derived CAR-T assets for €8 million upfront
    Armed Cell Therapeutics, a new Belgian biotech chaired by former Galapagos CEO Paul Stoffels, has taken ownership of several cell therapy programs previously held by Lakefront Biotherapeutics. The…
    BioPharma Dive · 29d agoDealPositive↗ source
  • FDA issues early alert on Edwards Lifesciences transcatheter mitral valve delivery system after balloon burst reports
    The FDA's Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with certain Edwards Lifesciences delivery systems used in the SAPIEN M3 transcatheter m…
    fda medwatch · 29d agoRegulatoryNegative↗ source
  • FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancer
    The U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that ha…
    fda press · 1mo agoApprovalPositive↗ source
  • CVS agrees to $315 million settlement over alleged improper opioid prescriptions
    CVS Pharmacy has agreed to pay $315 million to settle federal allegations that it dispensed unnecessary opioid prescriptions. The Justice Department claims the company filled prescriptions that we…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • Arrowhead’s experimental RNAi drug ARO-MAPT cuts tau protein by 73% in early human trial
    Arrowhead Pharmaceuticals said its experimental RNA interference therapy, ARO-MAPT, lowered the Alzheimer’s‑linked tau protein in a first‑in‑human study of healthy volunteers. The early‑stage tria…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Johnson & Johnson shares drop 6% after earnings meet forecasts but show weak medical device outlook
    Johnson & Johnson reported third‑quarter results that met Wall Street expectations and raised its 2026 financial guidance, yet the stock fell about 6% on the day. Analysts highlighted an underwhel…
    BioPharma Dive · 1mo agoEarningsNegative↗ source
  • FDA launches Rare Disease Framework Initiative to reshape drug development for small patient populations
    The FDA announced a new Rare Disease Framework Initiative aimed at overhauling how drugs and biologics for rare conditions are developed. The initiative will produce a tailored framework that refl…
    fda press · 1mo agoRegulatoryPositive↗ source
  • Verastem’s experimental KRAS drug shows early promise in small study, shares jump 18%
    Verastem Oncology announced early data from a small study of its experimental drug VS-7375, which targets the KRAS G12D mutation. The study enrolled patients with metastatic pancreatic ductal aden…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Par Health initiates voluntary recall of Argatroban injection after detecting particulate contaminants
    Par Health USA announced a voluntary nationwide recall of its Argatroban Injection 250 mg/2.5 mL product, affecting 22 lots that have been distributed to hospitals and users. The recall was trigge…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • BD and CareFusion recall Alaris Pump infusion sets due to serious performance risks
    The FDA has classified the recall of BD Alaris Pump infusion sets as the most serious type, warning that continued use could cause serious injury or death. BD and its subsidiary CareFusion sent an…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Convenience Kit Recall: AVID Medical Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall
    Avid Medical is removing certain convenience kits affected by the BD ChloraPrep Applicator Recall that may be contaminated with Aspergillus penicillioides.
    fda medwatch · 1mo ago↗ source
  • Roche signs $1 billion deal with China’s Rona Therapeutics for RNAi obesity drug
    Roche announced a new agreement with Chinese biotech Rona Therapeutics to acquire an experimental RNA interference therapy targeting the protein ALK7 for obesity. Under the terms, Roche will pay $…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Connectivity in fluid management systems key to reducing process variability
    The sponsored article, authored by Chris McCoy of Cytiva, highlights the often‑overlooked role of fluid‑management components such as tubing, connectors, and sensors in bioprocesses. It argues tha…
    BioPharma Dive · 1mo agoPositive↗ source